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Job Description FEFA, LLC seeks a Clinical Program Manager to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. This position will support research on infectious pathogens affecting military personnel and advance studies related to pathogen biology, host-pathogen interactions, and disease transmission. This role will primarily be responsible for overseeing day-to-day project operations, ensuring contract compliance, managing resources, and serving as the primary point of contact for the client and internal teams. Compensation: $105,000.00-125,000.00 per year. Key Responsibilities: • Lead the planning and implementation of project tasks, ensuring timely execution within scope and budget, • Interface regularly with the client, vendors, and internal stakeholders to ensure effective communication and project alignment, • Develop and maintain project documentation, schedules, and status reports, • Oversee onboarding and tasking of project personnel, ensuring role clarity and resource optimization, • Manage deliverables, track milestones, and proactively identify risks and mitigation strategies, • Provide regular updates to program leadership and ensure client satisfaction Project Management & Coordination • Provides day-to-day supervision of department-based research staff, ensuring efficient coordination of clinical research projects., • Manages the lifecycle of clinical research and bio surveillance studies, from protocol development through study implementation, data collection, and reporting., • Collaborates with internal and external stakeholders, including researchers, clinicians, sponsors, and regulatory bodies, to ensure smooth project execution., • Monitors project timelines, deliverables, and milestones, ensuring adherence to deadlines and budgets. Responsible for writing and reviewing monthly reports Budget Development & Management • Develops, negotiates, and monitors project budgets related to funded research initiatives., • Tracks and manages expenses, ensuring that projects remain within budget and align with the OID Directorate’s financial objectives., • Provides financial reports and updates to leadership, sponsors, and other key stakeholders as required. Regulatory Compliance & Quality Assurance • Ensures that all clinical research projects comply with Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, and relevant federal regulations., • Monitors for quality assurance throughout the clinical research process, conducting regular reviews of data accuracy, regulatory compliance, and adherence to study protocols., • Oversees the preparation and submission of regulatory documents, reports, and study-related correspondence. Staff Supervision & Development • Supervises and mentors clinical research staff, providing guidance and support to ensure high performance and professional growth., • Assigns responsibilities, oversees workload distribution, and conducts regular performance evaluations of clinical research team members., • Facilitates training opportunities for staff to stay current with clinical research best practices, regulatory requirements, and relevant scientific advancements., • Coordinate with public health, clinical, and operational partners to support timely data reporting and analysis. Direct and manage bio surveillance operations, integrating epidemiological data, syndromic surveillance, and lab results to identify and respond to emerging threats. Stakeholder Communication & Reporting • Serves as the primary point of contact for sponsors, funding agencies, and external partners, ensuring timely communication and coordination throughout the project lifecycle., • Prepares and presents project updates, progress reports, and final study findings to NHRC leadership and other stakeholders., • Participates in the writing and editing of scientific publications, abstracts, and presentations related to clinical research findings., • Develop and refine surveillance protocols, data-sharing agreements, and emergency response procedures. Team Leadership & Supervision: • Supervise and mentor a multidisciplinary team of research coordinators, clinical staff, and bio surveillance analysts., • Conduct performance evaluations, facilitate professional development, and support staff in meeting deliverables., • Foster a culture of collaboration, accountability, and scientific integrity. Regulatory & Compliance: • Ensure compliance with IRB requirements, DoD/NIH/FDA policies, and institutional procedures., • Maintain accurate records and support audit readiness through comprehensive documentation., • Manage adverse event reporting, protocol deviations, and other regulatory submissions. Strategic Planning & Communication: • Develop project plans, manage timelines, and lead initiatives under tight deadlines and high-pressure environments., • Support strategic planning for long-term research and surveillance priorities., • Communicate progress and findings clearly to leadership, sponsors, collaborators, and external partners. Other Duties as Assigned Qualifications: • Bachelor’s degree in Science, or related field (Master’s in public health or business is preferred), • PMP or equivalent project management certification (preferred), • Minimum 5 years of experience managing research projects/programs or similar complex projects with at least 2 years in a supervisory or leadership role, • Strong working knowledge of project management software (e.g., MS Project, Smartsheet), • Excellent communication, leadership, and organizational skills · Familiarity with REDCap, CTMS, or other clinical trial management platforms. · Clinical research certification (e.g., CCRC, CCRP) strongly preferred. Soft Skills Required: · Proactive Leadership & Communication: Effectively leads cross-functional teams, fosters collaboration, and communicates complex concepts clearly across clinical, research, and operational stakeholders. · Adaptability Under Pressure: Maintains composure and focus in high-stakes environments, adjusting to evolving priorities and tight timelines without compromising quality. · Strategic Thinking & Problem Solving: Anticipates challenges and identifies solutions, continuously looking for research growth opportunities, in both clinical trials and bio surveillance settings. · Emotional Intelligence & Team Development: Builds trust, supports staff development, manages change and demonstrates empathy and professionalism in all interactions. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required. Benefits FEFA, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: The Unit Clinician assists with the conduct of clinical trials through dispensing investigational drugs, the collection of biological samples, performing venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor’s written orders. In executing these responsibilities, the Unit Clinician is guided by Good Clinical Practices (GCP). Responsibilities: • Dispense and collect investigational products, routine medications, and PRN medications while subjects are housed on the site observation unit as dictated by written orders., • Perform appropriate research protocol procedures which may include but are not limited to vital signs, blood collection and processing, ECGs, and point of care laboratory tests., • Perform basic lab procedures including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups., • Ensure that biological specimens are disposed of appropriately., • Maintain a clean, safe work environment., • Study, learn and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable., • Education and experience, • Graduate / completion of approved accredited school of nursing. Education and requirements will be determined by the site need and protocol requirements., • Valid License as an RN in the state of practice; maintain current license., • Must have a minimum of one (1) year of clinical experience., • CPR Certification required, ACLS preferred for RN., • Phlebotomy certification (national) preferred., • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines., • Communicate with providers, co-workers, and others in a collaborative and courteous manner., • Knowledgeable in medical terminology to communicate with physician office and staff., • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change., • Requirements, • Ability to work independently and as a team player., • Ability to organize and prioritize within a changing environment., • Uses safety/universal precautions to protect self, subjects and staff., • Able to appropriately implement protocol and regulatory requirements in study conduct., • Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram., • Excellent documentation practices, • Good organizational and interpersonal skills, • Attentive to detail, good initiative and able to work with changing priorities.

Job Description Summary: Performs and manages all study-related clinical nursing procedures according to the study protocol and provides nursing care under appropriate supervision for subjects enrolled in clinical trials. Perform duties in accordance with ProSciento’s values, policies, and procedures. This is a temporary, 6-month per diem position averaging 2–3 shifts per week on a 12-hour shift, alternative work schedule (AWS). Please see the shift schedule below for our current scheduling needs. Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion. • Administers prescribed study medications, performs phlebotomy, draws blood samples, monitors vital signs, and/or performs other specialized nursing procedures, as appropriate to the specific needs of the study and individual subjects., • Starts peripheral intravenous lines using gauge 18 1 ¼” and double lumen catheter gauge 18 1 ¾” without use of tourniquets, as per specific study protocol., • Performs detailed review of subject’s current meds and enters information appropriately in source document as indicated., • Administers concomitant medications as indicated or prescribed., • Participates in day-to-day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects., • Completes study source documents for area of responsibility such as c-mar, fluid sheet, AE, and con med review., • Monitors and records subject response to treatment. Queries subjects on adverse events/serious adverse events during study. Completes study specific subject information serious event intake form., • Resolves study source document discrepancies., • Assists in keeping adequate stock of consumable clinical inventory., • Manages or assists with training of new hires, evaluating skills, maintaining crash cart, etc., • Provides supervision for research assistant and clamp tech staff in the performance of nursing related protocols involved in studies including assistance in training on the specifics of phlebotomy and blood draws, proper care of specimens, and properly obtaining urine samples., • Partners with the human resources department with respect to completion of procedures and processing including documentation and logistics for staff who have had exposure incidents., • Manages or assists with keeping employee immunizations up to date (TB, Hep B) including maintaining associated documents., • Develops synopses for nurse and research assistant use for each clinical trial., • Participates in training of other nurses and/or new hires in pertinent aspects of each protocol., • Assists in the training of research assistant staff for protocol-related and clinical procedure activities. Competencies: • Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources., • Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others., • Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgement; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience: Bachelor of Science in nursing as well as two years RN critical/acute care experience in a hospital, clinical research, and/or similar environment or an equivalent combination of medical education, training, certifications, and/or experience. Skills, Knowledge, and Abilities: Excellent IV skills necessary. Knowledge of immunizations for employers including record-keeping. Ability to work evening and overnight shifts, as required. Ability to conform to a 12-hour alternative work week shift schedule. Exercises calm judgment and actions under pressure. Demonstrates initiative and problem-solving skills. Able to respect subject confidentiality and blinding procedures. Understands medical terminology and calculations. Demonstrates a strong attention to detail with superior organizational skills. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Ability to self-monitor progress and complete assigned tasks independently. Certificates and Licenses: Active Registered Nurse (RN) license in the State of California. BLS & ACLS certification is required and may be provided by the company. Language Skills: Ability to read and interpret documents such as safety rules, Standard Operating Procedures (SOPs), Work Instructions (WIs), procedural manuals, governmental and clinical regulations, and similar documents. Able to communicate effectively to employees and management and in group meeting settings. Math Skills: Able to add, subtract, multiply, and divide in all units of measure using whole numbers, fractions and decimals. Able to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Skills: Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: To perform this job successfully an individual should have excellent computer skills with working knowledge of the current Microsoft Office Suite as well as Microsoft Windows operating systems. This is a temporary, 6-month per diem position averaging 2–3 shifts per week on a 12-hour shift, alternative work schedule (AWS). Current need: Primarily overnight shifts, 2–3 nights per week. Flexibility required: Candidates must maintain availability for a variety of shifts, including days, nights, weekends, and holidays, as scheduling needs may change.

Job Description What We Do: Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the utilization of oncolytic viruses through an allogeneic cell-based delivery system. Calidi Biotherapeutics is advancing this potent stem cell and oncolytic virus combination for use in multiple difficult-to-treat oncology indications. Our team is also developing a universal cell delivery system to protect, amplify, and potentiate oncolytic viruses currently in development. Job Overview/Summary: The Senior Associate I, Quality Control contributes to the quality of Calidi’s products and processes by overseeing external laboratory testing of GMP materials. This includes assurance that laboratory results are timely, reliable, and in accordance with all applicable regulatory requirements and internal procedures. This role collaborates cross functionally to develop, transfer, and qualify analytical methods, maintain global GMP inventory, qualify new suppliers, and support the strategic leadership of daily QC operations. Additionally, this position has supply chain tasks for inventory, clinical trial distribution, and sample logistics in compliance with regulatory standards. Ensures timely and efficient delivery of pharmaceutical products and materials across global operations while maintaining quality and traceability. Responsibilities: • Oversees external laboratory testing of GMP starting materials, in-process, release, and stability samples to ensure testing is performed in accordance with applicable internal procedures and specifications., • Reviews and approves QC procedures, test results, reports and production batch records. Conducts investigations into any out-of-specification results or laboratory deviations., • Implements appropriate corrective and preventive actions to address root causes and prevent recurrence., • Coordinates contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve, as needed., • Troubleshoots challenges while fostering a collaborative approach with external partners to support seamless and reliable QC operations., • Coordinates the stability testing programs for GMP materials, including reviewing stability data and reports, comparing test results against stability specifications, and establishing retest dates as appropriate., • Builds and maintains expertise in QC analytical processes and methods critical to oncolytic virus and cell therapy product development, manufacture, characterization, and release., • Supports development of test methods and procedures., • Facilitates method transfer from internal development to external partners, including overseeing laboratory testing during method qualification and validations activities., • Collaborates with Manufacturing to ensure incoming raw materials and components meet necessary quality requirements., • Works with Quality Assurance and external vendors to qualify new suppliers, implement appropriate sampling and testing of incoming materials, and review supplier-provided quality documentation., • Inventories GMP products and materials, including reference standards and critical reagents used in routine testing., • Prepares and maintains appropriate permits and documentation to support global shipment of regulated materials., • Provides CMC support on product development efforts related to formulation development, drug delivery device, container closure selection, packaging and labeling., • Collaborates with internal and external Manufacturing, Quality Assurance, Regulatory Affairs, and Development teams to support overall CMC activities of projects in the pipeline., • Participates in cross-functional meetings to address project timelines, tech transfer, and align on project objectives., • Plans and implements continuous improvement of methods, processes, and systems to assure compliant manufacturing of products., • Addresses inventory levels across multiple sites, ensuring accuracy, availability, and compliance with GMP/GDP standards., • Guides domestic and international shipping of products and ensure chain of custody, proper handling, storage, and transportation of temperature-sensitive and controlled substances., • Coordinates clinical trial material distribution, including investigational medicinal products and material supply as needed., • Leads sample logistics processes, including biological sample tracking, shipment coordination, and chain-of-custody documentation., • Develops and support all SOPs and procedures required to perform tasks related to supply chain, • Inform Technical Operations leaders as to progress, barriers/issues needing resolution and maintenance of timelines., • Other duties as assigned. Qualifications: • BS or higher degree in Life Sciences, Chemistry, or a related field (e.g., Chemistry, Biology, Immunology, Microbiology) and formal training in cGMP, cGCP, cGLP, regulatory requirements, • Minimum of 5 years of experience in a QC role in a GMP manufacturing environment., • Proven track of supply chain activities., • Broad knowledge of QC processes and procedures, LIMS systems, and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulations., • Excellent organization and project management skills. Mathematical Skills: • Ability to work with mathematical concepts such as calculation of dilutions and statistical analyses., • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Reasoning Ability: • Ability to define problems, collect data, establish facts, and draw valid conclusions. Language Skills: • Ability to read and understand technical procedures., • Ability to write protocols and reports., • Ability to effectively present data and respond to questions from co-workers., • Good verbal and written communication skills. The Perks: • Breakroom snacks and beverages, • Competitive Total Rewards package (Medical, Dental, Vision) offered to full-time employees, • Stock options Work Location: Calidi Biotherapeutics employment provides the opportunity to work in beautiful San Diego, California only minutes from the nearest beach. EOE and Accommodation We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Calidi Biotherapeutics provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may let the recruiting contact know. If you are selected to interview for a position, you may also request an accommodation with our team directly. Notice to Agency and Search Firm Representatives: Calidi Biotherapeutics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Calidi Biotherapeutics employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Calidi Biotherapeutics. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Employer’s Rights: This job description does not list all the duties of the job. You may be asked by supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. The job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason.

Job Description R&D Partners is seeking to hire a SCIENTIST, COMPUTATIONAL BIOLOGY in San Diego, CA. Your main responsibilities as a SCIENTIST, COMPUTATIONAL BIOLOGY: · Target Antigen Discovery: Lead efforts to identify and validate novel antigen targets for radiopharmaceutical therapy in oncology through integration of multi-omics data, including RNA sequencing, proteomics, and genomics. · Bioinformatics Analysis: Design and implement novel analytical frameworks to process, visualize and interpret high throughput sequencing and multiplex flow cytometry data from pre-clinical experiments, Real-World cohorts and internal clinical trial data to validate pharmacodynamics effects, confirm the mechanism of action, and enable patient enrichment strategies. · Collaboration: Work closely with computational biology colleagues, and engage with cross-functional teams, including discovery, translational, and clinical scientists, to provide bioinformatics expertise and guidance on experimental design. · Interpretation of Results: Generate hypothesis based on the analyses and present findings to both technical and non-technical stakeholders, providing actionable insights to inform radiopharmaceutical discovery and enable data-driven decision-making. · Oncology Expertise: Apply oncology expertise to understand the molecular mechanisms underlying cancer and therapeutic resistance, particularly in relation to radiopharmaceutical therapy. What we are looking for in a SCIENTIST, COMPUTATIONAL BIOLOGY: · PhD in Bioinformatics, Computational Biology, Cancer Biology, or a related field with 3+ of relevant industry experience. · Expertise in bioinformatics tools and software for RNA-seq, proteomics, and other omics data analysis. · Individual contributor role requiring strong background in -omic (DNA, RNA, epigenetic, proteomic) data analysis, biological interpretation and large-scale data analysis, particularly in oncology. · Proficiency in programming languages such as Python, R, and/or Perl, and experience with bioinformatics software and platforms. · Strong experience in statistical modeling and/or machine learning approaches, such as mixed-effects models, predictive modeling, etc. to represent biological concepts. Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO &, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval Pay Scale: $150,708 – $188,392 Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r\n\r\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\r\n\r\nOur life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

Job DescriptionSalary: $208,000 - $254,000 Job Summary We are seeking a highly motivated Medical Director, Clinical Development to lead the execution of our early-stage clinical programs (Phase III) who will report directly to the VP, Clinical Development. This individual will serve as the primary sponsor representative overseeing outsourced clinical trials run by CRO partners, ensuring scientific integrity, patient safety, and operational excellence. In our entrepreneurial environment, the Medical Director will be both strategic and hands-on, playing a central role in shaping our clinical development path while collaborating closely with internal stakeholders and external experts. The ideal candidate will work in our hybrid office a minimum of 3 days per week. Duties and Responsibilities • Contribute to the design and implementation of clinical development plans, protocols, and study designs in alignment with corporate goals and regulatory expectations., • Draft and review study-related documents including protocols, investigator brochures, IND amendments, and clinical sections of regulatory submissions., • Support the VP, Clinical Development in preparing presentations for executive leadership, board meetings, and scientific/medical forums., • Act as sponsor lead for Phase III trial(s), ensuring compliance with protocol, GCP, and regulatory standards., • Provide day-to-day oversight of study conduct and collaborate with internal cross-functional teams, CROs and other external vendors (eg, clinical operations, regulatory, data management, biostatistics, pharmacovigilance, medical writing)., • Partner with pharmacovigilance providers to ensure accurate, timely safety reporting., • Collaborate with Clinical Development Scientist team to ensure timely review of data listings, safety reports, and interim analyses to support timely, data-driven decisions., • Monitor trial progress and timelines proactively to identify and mitigate risks., • Participate in safety monitoring activities, including clinical review of adverse events, dose-escalation discussions, and safety data reconciliation., • Provide medical/scientific guidance to investigators and clinical sites., • Engage with key opinion leaders (KOLs)and investigators to inform study design and program advancement., • Contribute medical and scientific expertise to publications, abstracts, and presentations. What is Required • M.D. degree, • 3+ years of industry experience in clinical development, with direct involvement in Phase III oncology trials., • Knowledge and experience in solid tumor clinical trials preferred, • Understanding of drug development process, • Demonstrated success working with and managing CROs and vendors., • Experience authoring and reviewing protocols, regulatory documents, and clinical trial submissions preferred., • Knowledge of GCP, ICH guidelines, and U.S. and EU regulatory requirements., • Highly motivated with demonstrated track record of high performance and excellence, • Strong strategic skills including creativity and effectiveness in proactively identifying and addressing challenges, • Strong interpersonal skills and excellent verbal communication and presentation skills., • Well-organized with the ability to be flexible, prioritize multiple demands, and effectively lead in a matrix organization

Job DescriptionSalary: $208,000 - $254,000 Job Summary We are seeking a Director, Clinical Operations to provide trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions) for assigned studies. This role ensures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. The Director of Clinical Operations will directly report to the VP of Clinical Operations. The role is a hybrid position requiring 3 or more days on site in our San Diego, CA offices. Your Responsibilities • Oversee/monitor Clinical Trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations., • Safe and timely execution of Clinical Trial from sponsor role., • Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs. Ensure all Vendor contracts/legal documents current and on file at Alterome., • Metrics management as identified by Head of Clinical Operations., • Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial., • Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required., • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure., • Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines., • Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. Meets with vendors to ensure proper vendor oversight., • Supports financial management of the study which may include review and approval of site and vendor invoices., • Supports Risk Management initiatives. Proactively alert cross functional team to any risks identified and note suggested risk mitigation to identified risks., • Supports the filing of legal, team documents in SharePoint working Cross Functionally with Project Management, Clinical, Regulatory and Medical team members., • Maintain clinical trial registry entry/updates, as required., • Drives site start-up, subject enrollment, clinical monitoring activities, clinical site compliance and data metrics from CROs, central labs, and other external vendors., • Maintain direct contact and relationships with clinical sites participating in Alterome clinical studies to ensure high-quality and efficient execution of ongoing and planned clinical trial operations., • Leads development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc., • Performs administrative functions and additional duties as assigned., • Various activities in support of Clinical, Project Management, Regulatory and Medical team members. What is Required • BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered., • Approximately 10 years of direct site management (monitoring) experience, study management experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through Phase 3 studies, both domestic and international., • Phase 1 oncology experience managing dose escalation is required., • Prior Director, Associate Director, Clinical and/or Clinical Trial Manager experience., • Must have worked for a sponsor previously (only having worked at a CRO will not be considered relevant experience for this role), • Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines., • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines., • Perform independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas., • Ability to understand and analyze data/metrics and act appropriately., • Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills., • High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment., • Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships., • Works with high quality and has a compliance mindset.

Job Description We are seeking a highly motivated and qualified individual to join our Clinical Operations Department as a Director/Sr. Director, Clinical Data Management and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The Director/Senior Director of Clinical Data Management, reporting to the VP, Clinical Operations, will provide oversight for data management activities across ADARX’s clinical studies. This role involves building and leading a DM department, defining strategy, and establishing an efficient DM operating model. This role will be accountable for creating and maintaining data processes and standards, ensuring the seamless integration and quality of data from electronic data capture (EDC) systems and other clinical trial data sources. In addition, this person will be responsible for building the standards for data collection, edit specifications, Data Management Plans, data systems validation and UAT, listing generation, as well as review of clinical data for completeness, accuracy, and compliance Essential Responsibilities: • Oversee all Data Management activities for ADARX’s clinical trials, including oversight of vendors involved in clinical data management., • Lead and mentors CDM team members and contractors., • Review protocols and develop study plans to ensure that data collection and case report form (CRF) design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines)., • Create or review standards and specifications for CRFs, database build and validation, edit checks, external system integration, or for other systems and processes related to data while enabling near-real time data access for ADARx clinical trials., • Collaborate with clinical development, biostatistics and clinical operations to develop short-term and long-term strategies to improve data management quality and efficiency., • Accountable for deliverables to meet company goals., • Prepare for audits and regulatory inspections by ensuring data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans., • Provide subject matter expertise to study team members during all phases of the project life cycle, electronic data capture, external data standardization, and prior, during, and after internal and external audits and inspections., • Manage the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements., • Generate metrics, reports, dashboards, and analytics to measure the performance of Clinical Data Management team across the portfolio., • Represent clinical data management as a Subject Matter Expert (SME) and build relationships with key vendors., • Effective interaction with senior level management across multiple functions., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Maintain all appropriate corporate standards for facility safety. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • BS/BA degree or higher in science, mathematics, computer science or a health-related field., • At least 10 years of clinical data management experience in a regulatory environment in the pharmaceutical or biotechnology industry., • Experience successfully leading a CDM team or group., • Extensive background collaborating with CROs, vendors, and internal study teams., • In-depth knowledge and experience with clinical systems., • Possesses a comprehensive understanding of regulatory guidelines and industry standards and their application to DM., • In-depth knowledge and experience with clinical systems., • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Medrio experience is highly desirable., • Demonstrates an appropriate balance of business and technical capabilities., • Capable of actively identifying project challenges and risks and proposing appropriate and strategic solutions to issues., • Must be able to work independently as well in cross-functional team settings with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job DescriptionSalary: Who Are We? Founded in 1997 and built upon 27+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diegos Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. Who Are You? You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently. What is the Primary Objective of the Sr. Clinical Data Manager (CDM)? This position is responsible for data management activities, including developing data management plans, validating/testing databases, defining specifications to review data (manual, automatic (EDC edit checks), and SAS validations), and reviewing/tracking clinical trial data to ensure the completeness, accuracy, and consistency of the data collected during clinical trials. Study Specific Activities • Coordinate and complete data management activities to meet project timelines and communicate status to clinical project managers., • Develop study specific data management plans and case report form (CRF) completion guidelines., • Review and approve documents associated with data collection: CRFs, edit checks, data handling conventions, and data entry instructions., • Review and finalize clinical study database validation plans, lead the database validation team, and ensure all documentation is completed prior to GO-LIVE., • Complete data verification process (i.e., issue data clarification forms (DCFs) for paper CRFs or issue queries for EDC). Review completed DCFs and/or queries to ensure data discrepancies are resolved in the database., • Prepare electronic data transfer protocols and coordinate data transfers (imports and exports) with third party vendors and consultants and Project Biostatisticians., • Lead database cleaning and lock activities, coordinating data transfer reconciliation, serious adverse event reconciliation, and database audits with QA or data quality reviews with another Clinical Data Manager., • Ensure all study specific documentation is filed appropriately in the study-specific Trial Master File. General Activities • Manage and prioritize data management activities to meet project schedules., • Report on required data management metrics to ensure efficient review of data., • Develop data management resource forecasting and tracking model to assist with project planning and support., • Optimize database development and validation processes to improve departmental efficiency, • Train and mentor Clinical Data Associate(s) to develop clinical data review and other technical data management skills. To Succeed in this Position: • Ideally, you will have a Bachelors degree in a scientific discipline, at least 5 years of clinical data management experience in the pharmaceutical/biotechnology industry. More experience will be required for a senior level CDM candidate., • You must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. We prefer you to have MedDRA and WHO Drug coding proficiency., • You should have previous experience with reviewing data and database validation for EDC (Viedoc EDC is preferred) is required., • Knowledge of CDISC/SDTM standards is also highly desired., • If you are a remote-based candidate, you must reside and work in the PST, MST, or CST time zone. If you are a local candidate based in San Diego County, you will be required to work onsite at our San Diego office following a hybrid schedule. The most likely starting base pay range for this position is $120,000 - $130,000 per year depending on title, experience-level of the candidate, location and particular business needs. Consideration will be given to experience that exceeds the listed requirements. We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.If you are smart and good at what you do, we welcome you to apply!

Job Description:\n\n In San Diego, the starting hourly base rate for Team Jeni’s Ambassadors is $20.00/hour but our Ambassadors have the opportunity to earn an average of $30.46 per hour!* *This is an estimate of hourly earnings. It is based on the 2025 base pay rate, plus 2024's hourly tip average. 2025 actual customer tips may vary. Jeni’s Splendid Ice Creams is searching for Ambassadors to join our North Park team. At Jeni’s, we’re devoted to making better ice creams and bringing people together. Our scoop shops are at the heart of how we serve this mission. They are where we offer the ice creams we work so hard to build from the ground up—where people come together to share joy and conversation. We love people. We love ice cream. We view ice cream as a form of art. Team Jeni’s Ambassadors are our part-time, front-line crew members. They scoop and serve ice cream to our customers, make waffle products, run the register, keep the shop clean, change out buckets of ice cream, and perform a number of other important, related tasks. As an Ambassador, you will: Serve the ice cream Time magazine calls “the best in America” Gain valuable real-world business and entrepreneurship experience Work in an environment oriented around serving each other and making people’s day Have opportunities for growth within a growing company Receive competitive compensation Qualities of an Ice Cream Ambassador (also known as a scoop shop employee): Exhibit passion for community, an eye for detail, a willingness to clean (a lot), stamina (to serve people in long lines), and the ability to work in a fast-paced environment Familiar with (and be able to articulate to customers) what distinguishes Jeni’s Splendid Ice Creams from other ice creams, and be able to articulate that to the 500th customer with the same care and presence as the 1st customer Available to work weekends, late nights (past 11 p.m.) Provide consistent, world-class service to every single customer Reliable, on time, and ready to hustle for every shift Committed to the well-being of their shop team, their community, and the environment around them About Jeni’s Splendid Ice Creams: Founded by Jeni Britton in 2002, Jeni's Splendid Ice Creams is a certified B Corp headquartered in Columbus, Ohio, with scoop shops in over twenty cities across the country, making it possible for members of Team Jeni’s who are interested in developing their careers, or transitioning to a new city, to have meaningful opportunities to learn, grow, and explore. Our Ambassadors make a difference in their shop, their community, and in how they partner with their team and serve their customers. If this opportunity sounds delicious to you, please apply. Jeni's is an equal opportunity employer. Said our way, we love and honor differences, and we love sharing common values such as talent, hustle, guts, resilience, and empathy. Our differences are a primary source of our team's strength and we crave having a team rich with diversity which is creativity and art in its human form. ___ NOTICE PURSUANT TO THE CALIFORNIA CONSUMER PRIVACY ACT AND CALIFORNIA PRIVACY RIGHTS ACT Effective Date: July 1, 2020 Last Reviewed on: December 7, 2023 Introduction This Privacy Notice (the “Privacy Notice”) is adopted to comply with the California Consumer Privacy Act of 2018 as amended by the California Privacy Rights Act of 2020 (“CCPA”). Any terms defined in the CCPA have the same meaning when used in this Privacy Notice. Jeni’s Splendid Ice Creams, LLC (“Jeni’s”) is committed to protecting the privacy and security of personal information. In the course of our business, we may ask job applicants, prospective employees and employees (“you” or “your”) to provide personal information relating to your employment or prospective employment. This Privacy Notice describes how Jeni’s collects and uses personal information, the categories of personal information we collect and instances when the personal information may be disclosed to third parties. Jeni’s will only collect and process personal information in accordance with this Privacy Notice, unless otherwise required or permitted by applicable law. Information We Collect We collect information that identifies, relates to, describes, references, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular individual ("Personal Information"). Further, under California law certain data elements are classified as Sensitive Personal Information (“SPI”). Collection of such data provides possible additional rights to California employees (see Your California Privacy Rights). Below is a list of data elements that are classified as SPI:  Identifying Information: SSN, Driver’s license number, passport/visa information, immigration information  Demographic data: Race, ethnic origin  Financial Information: Banking details  Health and safety information: Employment-relevant health conditions, workplace illness  IS information: contents of user’s mail, email, or text messages  Biometric Information: Facial recognition scans, fingerprints, iris/retina scans, and keystroke or other physical patterns  Geolocation Data: Precise physical location  Other SPI: religious/philosophical beliefs, union membership, sexual orientation, credit card number/access code, genetic data Personal Information does not include:  Publicly available information from government records.  Deidentified or aggregated consumer information.  Information excluded from the CCPA’s scope, like: o Health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data; o Personal Information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FCRA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver's Privacy Protection Act of 1994. Jeni’s has and may continue to collect the following categories of personal information from employees, applicants and contractors for the purposes stated below, as well as the following purposes: efforts to recruit employees, administration of benefits, paying and reimbursing expenses, managing your employment relationship with us, conducting performance related reviews, accounting and human resource services, assisting in case of emergency, monitoring eligibility to work in the U.S., ensuring a safe and efficient working environment, facilitating a better working environment, maintaining security, and compliance with applicable laws and regulatory requirements, conducting internal audits and workplace investigations, investigating and enforcing compliance with and potential breaches of Jeni’s policies and procedures, engage in corporate transactions requiring the review of employee records, maintaining commercial insurance policies and coverages:  Pre-Hire Documents: job application and/or resume, cover letter with salary requirements, prior employment history, education information, background check information, drug test information, job interview notes, candidate evaluation records, written recommendations or notes from reference interviews. This information is collected for the above stated purposes and to comply with local, state and federal law requiring employers to maintain such records, to effectively hire qualified candidates, etc. and to assess qualifications for a particular job or tax, conduct performance reviews and determine performance requirements. Jeni’s will not collect additional categories of personal information or use the personal information collected for materially different, unrelated, or incompatible purposes without first providing you with additional and/or updated notice. We do not share your personal information as defined under Cal. Civ. Cd. 1798.140(ah). Disclosure to Third Parties Jeni’s does not sell or otherwise disclose your personal information to any third parties for any monetary consideration. Jeni’s only shares your personal information with service providers to the extent necessary in order to administer employee benefits, including for payment of wages, tax processing, and health insurance, and in connection with its human resource activities. Jeni’s also discloses your information when required by local, state, or federal law. Retention Schedule We will retain your personal information for no longer than is necessary for the purposes noted above, unless otherwise extending the retention period is required or permitted by law or subject to our retention policies as may be in place from time to time. Your Rights and Choices Under California Law The CCPA provides California employees with specific rights regarding their personal information. This section describes CCPA rights and explains how to exercise those rights. Access to Specific Information and Data Portability Rights You have the right to request that we disclose certain information to you about our collection and use of your personal information over the past 12 months. Once we receive and confirm your verifiable consumer request, we will disclose to you:  The categories of personal information we collected about you.  The categories of sources for the personal information we collected about you.  Our business or commercial purpose for collecting or selling that personal information.  The categories of third parties with whom we share that personal information.  The specific pieces of personal information we collected about you (also called a data portability request).  If we disclosed your personal information for a business purpose, a list of the disclosures made identifying the personal information categories that each category of recipient obtained. Correct/Rectify Personal Information You have the right to rectify (correct, update, or modify) the personal information we collect about you. After making such a request, we will take commercially reasonable efforts to correct inaccurate personal information within 45 days of receiving the request. In the event an extension is needed, we may take an additional 45 days when reasonably necessary. In this case, We will provide you a notice of extension within the first 45-day period. Deletion Request Rights You have the right to request that we delete any of your personal information that we collected from you and retained, subject to certain exceptions. Once we receive and confirm your verifiable consumer request, we will delete (and direct our service providers to delete) your personal information from our records unless an exception applies. We may deny your deletion request if retaining the information is necessary for us or our service providers to:  Fully carry out your relationship with us as an employee or job applicant  Detect security incidents, protect against malicious, deceptive, fraudulent or illegal activity, or prosecute those responsible for such activities.  Debug products to identify and repair errors that impair existing intended functionality.  Exercise free speech, ensure the right of another consumer to exercise their free speech rights or exercise another right provided for by law.  Comply with the California Electronic Communications Privacy Act (Cal. Penal Code § 1546 seq.).  Engage in public or peer-reviewed scientific, historical or statistical research in the public interest that adheres to all other applicable ethics and privacy laws, specifically if you previously provided informed consent and deleting that information may seriously impair or render impossible the research’s achievement.  Enable solely internal uses that are reasonably aligned with consumer expectations based on your relationship with us.  Comply with a legal obligation.  Make other internal and lawful uses of personal information that are compatible with the context in which you provided it. Exercising Access, Rectification, Data Portability, and Deletion Rights To exercise the access, rectification, data portability and deletion rights described above, please submit a verifiable request to us by either:  Calling us at 614.360.2565  Via Email at . You may only make a verifiable consumer request for access or data portability twice within a 12-month period. The verifiable consumer request must:  Provide sufficient information that allows us to reasonably verify you are the person about whom we collected personal information or an authorized representative.  Describe your request with sufficient detail that allows us to properly understand, evaluate and respond to it. We cannot respond to your request or provide you with personal information if we cannot verify your identity or authority to make the request and confirm the personal information relates to you. Making a verifiable consumer request does not require you to create an account with us. We will only use personal information provided in a verifiable consumer request to verify the requestor’s identity or authority to make the request. Response Timing and Format Per CCPA requirements, we will confirm receipt of a consumer’s request within 10 days. We will try our best to respond to a verifiable consumer request within 45 days of its receipt. If we require more time (up to 90 days), we will inform you of the reason and extension period in writing. We will deliver our written response by mail or electronically, at your option. Any disclosures we provide will only cover the 12-month period preceding the receipt of the verifiable consumer request’s receipt. The response we provide will also explain the reasons we cannot comply with a request, if applicable. For data portability requests, we will select a format to provide your personal information that is readily useable and should allow you to transmit the information from one entity to another and should allow you to further transmit information if you desire. We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive or unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request. Non-Discrimination We will not discriminate against you for exercising any of your CCPA rights. Based solely on the exercise of your CCPA rights. Changes to This Privacy Notice Jeni’s reserves the right to update this Privacy Notice at any time and will provide you with a new Privacy Notice when and if any updates are made. To ask questions or comment about this Privacy Policy, contact .

Job Description Summary/objective For over 40 years, IABA has been providing high quality, person-centered treatment for children and their families. We take pride in the positive changes we make in our community. As a Behavior Interventionist with IABA, you will serve as a key member of our team, specializing in delivering evidence-based, person-centered interventions to support children with developmental disabilities like Autism Spectrum Disorder. In this role, you will have the opportunity to make a profound impact on the lives of children with disabilities by implementing personalized treatment plans, fostering skill development, and promoting positive behavior change. Your primary goal is to provide one-to-one intensive intervention, assisting clients in developing the skills necessary to be integrated into school and other community settings Using the principles of Applied Behavior Analysis (ABA), you will provide one-on-one support in the home and community, using our positive-only methods to reinforce desired behaviors, and enhance play, self-care, cognitive, social, and communication skills. Essential functions Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Hours of Need: PART-TIME Monday-Friday from 2pm-7:30pm (10-20 hours of work per week) Servicing North San Diego County Duties: • Direct intervention with child/family, • Keep accurate client records, • Maintain accurate administrative records, • Drive between sites, • Attend/Participate in Training Administrative/Non-Clinical • Proficiency with Microsoft Office, including data entry in Microsoft Excel and Microsoft Word for purposes of recording data in digital logbooks., • Proficiency with web-based online learning platforms., • Able to simultaneously take accurate data while conducting discrete trials (80% data reliability as measured by supervisor observation)., • Able to implement behavior support plan as outlined in Behavior Intervention Plan and/or MEBS plan by implementing proactive and reactive strategies accurately (80% implementation reliability as measured by supervisor observation)., • Able to implement case-specific differential reinforcement procedures (DRO and DRA) for the duration of session (as measured by supervisor observation)., • Able to implement discrete trial teaching strategies according to SD-R-SR+ criteria (with 80% fidelity as measured by supervisor observation)., • Able to implement least-to-most prompting strategies (with 80% fidelity as measured by supervisor observation). No supervisory responsibilities Work environment While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, grasp or feel; reach with hands and arms; push and pull, and talk, hear and smell. The employee is occasionally required to stoop, kneel, or crouch. Employee in this position may encounter prolonged sitting and/or standing. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus Requirements Required education and experience • High school Diploma required, • Prior job-related experience with Applied Behavior Analysis working with children with autism or other developmentally delaying disorders (preferred), • Bachelor’s degree (preferred), • Must pass LIVESCAN (DOJ/FBI), provide DMV printout, Valid Driver's license proof of insurance, and current TB clearance. first aid and CPR training, • COVID-19 Vaccination Requirement:, • Where permitted by applicable law, new hires must have received the COVID-19 vaccine. The Company will consider reasonable accommodations to qualified employees with disabilities or for a sincerely held religious belief., • Affirmative Action/EEO statement, • It is the policy of IABA to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable, • Other duties • Competitive pay based on experience and ABA coursework, • Earned Paid Time Off/Vacation (for full-time employees), • Paid Sick Time, • Regular training, support, and mentorship from IABA Supervisors, • Health, Dental, and Vision insurance (for full-time employees), • Comprehensive paid training both when you are hired and ongoing, • Potential to receive BCBA supervision hours when enrolled in a qualified Master's program, • Paid Drive Time & Mileage, • Excellent opportunities for advancement, • Opportunities to earn rewards and recognition based on performance on clinical and administrative tasks, • Cell phone reimbursement

Job Description Summary/objective For over 40 years, IABA has been providing high quality, person-centered treatment for children and their families. We take pride in the positive changes we make in our community. As a Behavior Interventionist with IABA, you will serve as a key member of our team, specializing in delivering evidence-based, person-centered interventions to support children with developmental disabilities like Autism Spectrum Disorder. In this role, you will have the opportunity to make a profound impact on the lives of children with disabilities by implementing personalized treatment plans, fostering skill development, and promoting positive behavior change. Your primary goal is to provide one-to-one intensive intervention, assisting clients in developing the skills necessary to be integrated into school and other community settings Using the principles of Applied Behavior Analysis (ABA), you will provide one-on-one support in the home and community, using our positive-only methods to reinforce desired behaviors, and enhance play, self-care, cognitive, social, and communication skills. Essential functions Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Hours of Need: PART-TIME Monday-Friday from 2pm-7:30pm (10-20 hours of work per week) Servicing South San Diego County Duties: • Direct intervention with child/family, • Keep accurate client records, • Maintain accurate administrative records, • Drive between sites, • Attend/Participate in Training Administrative/Non-Clinical • Proficiency with Microsoft Office, including data entry in Microsoft Excel and Microsoft Word for purposes of recording data in digital logbooks., • Proficiency with web-based online learning platforms., • Able to simultaneously take accurate data while conducting discrete trials (80% data reliability as measured by supervisor observation)., • Able to implement behavior support plan as outlined in Behavior Intervention Plan and/or MEBS plan by implementing proactive and reactive strategies accurately (80% implementation reliability as measured by supervisor observation)., • Able to implement case-specific differential reinforcement procedures (DRO and DRA) for the duration of session (as measured by supervisor observation)., • Able to implement discrete trial teaching strategies according to SD-R-SR+ criteria (with 80% fidelity as measured by supervisor observation)., • Able to implement least-to-most prompting strategies (with 80% fidelity as measured by supervisor observation). No supervisory responsibilities Work environment While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, grasp or feel; reach with hands and arms; push and pull, and talk, hear and smell. The employee is occasionally required to stoop, kneel, or crouch. Employee in this position may encounter prolonged sitting and/or standing. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus Requirements Required education and experience • High school Diploma required, • Prior job-related experience with Applied Behavior Analysis working with children with autism or other developmentally delaying disorders (preferred), • Bachelor’s degree (preferred), • Must pass LIVESCAN (DOJ/FBI), provide DMV printout, Valid Driver's license proof of insurance, and current TB clearance. first aid and CPR training, • COVID-19 Vaccination Requirement:, • Where permitted by applicable law, new hires must have received the COVID-19 vaccine. The Company will consider reasonable accommodations to qualified employees with disabilities or for a sincerely held religious belief., • Affirmative Action/EEO statement, • It is the policy of IABA to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable, • Other duties • Competitive pay based on experience and ABA coursework, • Earned Paid Time Off/Vacation (for full-time employees), • Paid Sick Time, • Regular training, support, and mentorship from IABA Supervisors, • Health, Dental, and Vision insurance (for full-time employees), • Comprehensive paid training both when you are hired and ongoing, • Potential to receive BCBA supervision hours when enrolled in a qualified Master's program, • Paid Drive Time & Mileage, • Excellent opportunities for advancement, • Opportunities to earn rewards and recognition based on performance on clinical and administrative tasks, • Cell phone reimbursement

Job DescriptionAbout Radionetics Radionetics Oncology, Inc. is a clinical stage radiopharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology spun out of Crinetics Pharmaceuticals (Nasdaq: CRNX) and is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments. Radionetics is advancing a pipeline of novel small molecule radioligands targeting G-protein coupled receptors for the treatment of a broad range of cancers, including adrenocortical carcinoma, breast cancer, lung cancer, among others. For more information, visit . The Director/Senior Director, Clinical Scientist reports directly to the Chief Medical Officer and plans, implements, and manages assigned clinical research studies in collaboration with internal and external stakeholders to ensure trial integrity and success. The Clinical Scientist provides strategic input and development support for clinical plans, evaluating and interpreting clinical data reviewing and authoring study-related documents, monitoring patient data and data collection status, and delivering protocol-related training to CROs and clinical trial sites. The Clinical Scientist provides support for preparation of regulatory submissions necessary for the initiation of clinical studies. This position is a key cross-functional team member contributing to the design and execution of the company’s clinical trials. Essential job functions and duties • Support the creation of the clinical development plan in partnership with cross- functional team members as well as KOLs and CROs., • Author, manage, and review study materials for competent authorities’ submissions; gain insights from clinical and scientific experts (e.g. protocol, regulatory documents, study report, safety review and communication)., • Analyze and interpret clinical trial data, collaborating with clinical operations to conduct data review., • Troubleshoot internal and external conflicts to ensure trial integrity and success., • Develop and present protocol training for CROs and trial sites., • Engage with trial sites and CROs on an on-going basis to monitor subject data and data collection status, ensure adherence to protocol, and evaluate consistency of data., • Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices., • Establish excellent communication and collaboration with the cross-functional partners within the company and outside of the company., • Deliver timely, high-quality clinical study data, working in concert with external and internal partners., • Collaborate with clinical operations to identify, recruit, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators to prioritize enrollment and ensure timely and high-quality execution of clinical studies., • Support clinical operations in the selection, contracting, and oversight of CROs and vendors in assigned projects., • Work closely with clinical department team members and other stakeholders to develop and drive patient accrual strategy to meet appropriate corporate timelines., • In assigned projects, lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP edit checks, safety plan, Safety Management Team and DMC charter, close-out plans, inspection readiness plans, and CSRs., • Lead the development of study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring boards., • Lead in writing publications and scientific presentations., • Perform other responsibilities as required by business needs.Minimum required qualifications, • Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred., • Minimum 10 years (director) or 12 years (Senior director) of experience with 5+ years as a Clinical Scientist or comparable role., • Solid knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution., • Experience in a scientific discipline with clinical drug development experience and strategic planning specifically in the pharmaceutical or biotech industries is preferred; however, other relevant experiences and skills may be considered., • Experience in oncology is preferred, radiopharmaceutical experience is a plus., • Highly motivated and thrives working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient., • Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations., • Self-starter who can lead and manage function independently, while utilizing sound judgment.Non-standard work schedule, travel or environmental requirements, • The position is based in San Diego, CA; a portion of the job duties may be performed remotely. Pay Range: $208,000 - $240,000 (director range); $250,000 - $280,000 (sr. director range) Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California. Important notices Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class. The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time. Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics. Powered by JazzHR PVMo2sgj5Z

Job Description Vivo HealthStaff is recruiting for a Clinical Trials Physician for a Vaccine Trial in the USA. We are seeking an experienced and licensed Pain Management Physician to provide locum tenens coverage at multiple clinic locations across the USA. The ideal candidate is board certified, has a current medical license, and is looking for contract work. Position Details: Specialty: Clinical Trials Start Date: [Flexible Based on Availability] Contract Length: 3-12 months, with extension potential Schedule: 1-2 days per week Call: No call required Practice Setting: Outpatient clinic Locations Available: * Washington DC * San Diego, CA * Denver, CO * San Jose, CA Responsibilities: * Evaluate patients for a vaccine trial * Collaborate with clinic staff and specialists for comprehensive clinical trial * Use EMR for documentation Requirements: * Active and unrestricted Medical License * Active DEA registration * Prior experience in Clinical Trials Compensation & Benefits: Pay Rate: Competitive hourly rate Payment: Weekly direct deposit Insurance: Malpractice insurance provided Support: Dedicated recruiter assistance throughout the assignment Onboarding Process: Expedited credentialing available Assistance with compliance and facility paperwork Orientation provided before the start date About Vivo HealthStaff: Vivo HealthStaff is a locum tenens staffing firm specializing in placing healthcare professionals in temporary and long-term assignments across the United States. We are committed to providing seamless placement experiences for providers and healthcare organizations.

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our Legal Department as a Contract Attorney and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, and highly flexible within a fast-paced environment. In the Contract Attorney role, this individual will be the primary contact responsible for drafting and negotiating a wide range of contracts and will actively collaborate with colleagues across disciplines and contribute toward creative problem solving. Our ideal candidate will bring strong relevant law firm or in-house experience. In this role, the individual will have the opportunity to interact and collaborate with all levels of the organization including our clinical, research and finance teams as well as external organizations. This role is expected to grow with the company as we discover and develop life-saving therapies for patients in need. Essential Responsibilities: • Manage company CLM, including tracking and monitoring all requests, ensuring proper recording of contracts on the system, and tracking of important legal provisions., • Draft, review and negotiate contracts across all areas of the organization, including but not limited to, non-disclosure, vendor, collaboration, licensing, and clinical trial agreements., • Draft and update appropriate templates and work with stakeholders to develop contract strategies to support the organization., • Engage appropriate internal subject matter experts to assist with and participate in information gathering, document development, contract and issue reviews, and contract negotiation., • Prepare contract summaries to assure proper interpretation of contracts (e.g., milestones, obligations, deliverables, invoicing etc.) and advise on same., • Generate reports and respond on a timely basis to ad hoc data requests from internal stakeholders., • Drive increased efficiency, coordination, and effectiveness of contract processes to meet the needs of the business., • Provide training and guidance on contract processes to internal stakeholders., • Presentation of results in both written and oral format and delivery of completed reports within a multidisciplinary team., • Support internal stakeholders on key commercial, legal, corporate policy and other considerations to ensure timely performance and adherence to terms of contracts., • Work collaboratively with IT, Finance, and other internal stakeholders to implement and manage enhancements to systems., • Establish and maintain excellent working relationships with external stakeholders., • Maintain all appropriate corporate standards for facility safety. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Juris Doctor (J.D.) from an accredited law school., • Minimum 3+ years of experience of corporate contract experience, including developing, negotiation and managing a wide variety of contracts., • Current on legal/regulatory updates affecting contracts and agreements., • Strong analytical skills., • Demonstrated organizational skills and ability to manage multiple projects at once, drive execution and meet critical deadlines., • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Strong communication, interpersonal, and negotiation skills; excellent oral and written communication skills with experience in reviewing and redlining legal documents., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • Prior in-house experience in a public biotech and/or pharmaceutical company preferred., • Experience managing CLM software a plus., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director/ Director, Drug Safety will be responsible for maintaining Arrowhead's safety database, preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for the clinical programs Responsibilities • Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close., • Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility., • Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems, • Prepare, support and track PVAs/SDEAs with partners., • Monitor compliance with partner Safety related activities needed as per PVA/SDEA., • Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors., • Review vendor scope and assist with study level budgets as needed., • Provide vendor oversight, including tracking KPI's and collaborate with multiple vendors for process setup & improvements., • Perform and manage SAE reconciliation between databases., • Responsible for data clean-up and data migration from vendor Safety database., • Oversee submission activities for ICSRs and aggregate reports., • Collaborate with vendors for TMF Safety documents filing and review., • Manage day to day operation of Safety database., • Ensure that reported SAE (and events of special interest to include pregnancy and overdose) event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations and Arrowhead Management Plans/SOPs., • Coordinate with vendors to ensure all internal/external timelines are met per PVA and ensure, potential issues are communicated, and resolution is achieved in a timely manner., • Support activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators., • Support other members of Safety Operations and Science personnel and ensure flawless execution of Safety and Pharmacovigilance processes, • Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead's drug Safety and Pharmacovigilance., • Facilitate the analysis of similar events for expedited safety reports occurring in pre-marketed clinical studies., • Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations., • Provide drug safety case management support to Safety medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data., • Assist with the development and maintenance of departmental SOPs and other procedural documents., • Support reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety, • Support the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed, • Help in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies, • Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies, • Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety, • Participate in inspection-readiness activities to included document and eTMF support., • Collaborate with Regulatory personal and CROs to communicate upcoming SAEs requiring expedited submissions to Regulatory Authorities, to include ad hoc reporting responsibilities form Arrowhead Safety., • Support the Manager of Safety Operations and Head of Clinical Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations), • Informs Manager of safety related issues and potential trends and or signals arising from review of post-marketed safety data., • Assist with safety database test configurations., • Assist with review of cross-functional documents/plans (e.g., protocols, SAE Reconciliation Plans, etc.), • Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations., • Help in managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results, • Support monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements, • Maintenance of Arrowhead safety operations documentation (e.g., safety case files), and management of the Safety Mailboxes., • Help in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements, • Participate in the production and validation of appropriate safety data output from the external or internal safety database for required safety deliverables (e.g. DSUR, IB, ad hoc analyses etc.)., • Manage Arrowhead's QMS for safety/Pharmacovigilance procedures, • Participate in and Help with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities, • Responsible for UAT and Implementation of updates within Safety Database., • Responsible for Argus console activities like maintaining user sites, groups, accounts, workflow, product, study configurations, and reporting rules., • Perform periodic MedDRA and WHO Drug upgrades., • Assist with periodic Disaster recovery and Business continuity tests as needed with Safety Database., • Support Drug Safety team with listings and data from the Argus database., • Minimum of BS/BA degree in a health-related area (RN/BSN) and 8 years in the pharmaceutical industry or CRO, • 5-10 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience, • Prior experience in Safety/Pharmacovigilance Operations is required., • Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications, • Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs), • Working experience with Safety Databases (Argus, ArisG or other) is required., • Knowledge of ICH E2B guidelines in clinical and post-marketing studies. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionSalary: Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies. We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a white glove service approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients needs as they evolve. Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results. Position Overview: This is an exciting opportunity to join a young and lively company in a fast-paced and dynamic environment. The Director, Business Development is responsible for all phases of the development of the companys future revenue stream through new account targeting and development. Essential Duties & Responsibilities: • Develop and generate new business development leads., • Work with targeted business development accounts to secure future business., • Develop and implement projects, programs and strategies to accomplish corporate objectives., • Develop materials and presentations demonstrating CRO services according to client specifications and needs., • Prepare and/or assist in the preparation of price quotations, terms of sale and timelines according to company policy and within corporate guidelines., • Monitor monthly time and activity versus productivity to assess and implement continuous improvement., • Interview prospective new team members., • Supervise and conduct employee training/continuing education and performance evaluations., • Other duties as assigned. Experience & Skills: • A business background in the sales, training, marketing or purchasing of clinical service offerings for CROs, FSPs, and/or consulting businesses in the drug or device development space., • 7+ years in pharmaceutical, medical device or related experience highly preferred., • Strong experience in computer technology, including CRM usage, • Foundational background/knowledge regarding medical terminology, drug nomenclature, clinical operational offerings, • Demonstrated character and transparency in prior business ventures, • Possesses a true passion for improving patient outcomes through the clinical development process, • Good written and oral communication skills., • Ability to work independently and be self-motivated., • Ability to function as a team member., • Ability to lead and delegate to others., • Ability to identify client needs/opportunities and translate them into new projects., • Excellent interpersonal communication skills., • Ability to interact and develop a rapport with clients. Education: Bachelor's degree in life science from an accredited college or university is strongly preferred; may be replaced by relevant experience. Other bachelor's degrees with relevant industry experience will be considered. Travel: Travel of up to 75% may be required. Compensation Range: Full-time Position: $130,000 -$160,000 base pay with generous uncapped commission structure + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off) Consultant Rate: will be DOE COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws. Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Job Description General Position/Summary: The Executive Director/Vice President of Clinical Operations is responsible for the oversight of CROs and clinical operations FTEs, and planning, oversight, and execution of clinical trials. This position reports directly to the Chief Medical Officer. Key Responsibilities: The responsibilities for this position may include, but are not limited to, the following: • Oversee the planning, execution, and management of clinical trials across all phases of development from study concept, protocol implementation, to study close-out, • Creating and ensuring adherence to study timelines, budgets, and quality standards, while minimizing risks and maximizing operational efficiency, • Manage Clinical Trial Managers/ Clinical Trial Assistants with responsibility for resourcing, training, performance management, employee goal setting and career development. May also manage contract staff, • Develop operational strategy (study scenario planning, operational decision points and risks, initial study timeline, study financials) for assigned program(s), • Accountable for operational delivery of all clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout, • Proactively identifies study and program risks and implements contingency plans providing regular updates on study status to stakeholders, • Participates in vendor identification and oversees Clinical Trial Managers in vendor set up and oversight, • Cultivate strategic partnerships with key vendors and stakeholders to drive excellence in clinical trial execution, • Active involvement in investigator identification and selection, including the expansion to new geographies, • Provides oversight on the development of study documentation, including clinical trial protocols, study plans and clinical study reports., • Participates in cross functional study data review where appropriate, • Periodic travel to investigational sites, Investigator Meetings and therapeutics conferences/congresses, • Facilitate effective communication and collaboration among cross-functional teams, including clinical operations, clinical development, regulatory, clinical supplies, and safety, • Bachelor’s degree in life sciences discipline or relevant discipline, • At least 10 years of experience executing clinical trials globally across all phases of development and 2 years of supervisory/management experience, or the equivalent combination of education and experience., • Extensive knowledge of clinical trial regulations, guidelines, and standards, • Proven track record of successfully leading and managing clinical study teams and executing global clinical trials across various therapeutic areas., • Proficiency in utilizing Microsoft365 and project management tools, • Strong leadership, communication, and interpersonal skills, • Demonstrated ability to work flexibly and effectively in a fast-paced, team-oriented, ‘start-up’ environment, • Excellent organizational and problem-solving skills with attention to detail, • This position may require up to 20% domestic and/or international travel Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Protego offers competitive benefits including medical, dental, vision, employer paid life and long-term disability insurance, 401(k) match, PTO and federal holidays.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Quality Control Laboratory Associate I is responsible for ensuring that only quality products are released for distribution. It is a QCLAI’s job to ensure that products are tested to meet the applicable government regulations and industry standards, and to maintain GMP environment. The Quality Control Laboratory Associate is also responsible for data entry. Core Responsibilities Include: • Effectively maintain the Standard Operating Procedures (SOP), acceptance criteria, etc. for the department and products tested., • Effectively and efficiently test raw materials, in process, and final products, and generate testing data., • Conduct and maintain the real time stability study testing., • Maintain inventory materials used in quality control., • B.S. degree in a scientific discipline and, typically, 0-2 year(s) of applicable experience; equivalent combination of education and experience may be considered. Internships and/or other related experience preferred., • Familiarity wtih polymerase chain reactions, gel electrophoresis, capillary electrophoresis, next generation sequencing, DNA/RNA isolation and purification, and cDNA synthesis is preferred., • Familiarity with 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, NanoDrop Spectrophotometer, iBright, and single and multichannel pipettes., • Familiarity with medical device quality and regulatory requirements including QSR and ISO quality system standards, the IVD Directive and IVD Regulation is preferred., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Sourcing and Procurement Specialist II for evaluating and recommending sourcing strategy for the procurement of goods and materials to include contract management, negotiation and vendor relationships. S/he will identify new sources to meet new business requirements and continuously measure effectiveness and cost savings. Core Responsibilities Include: Procurement: • Perform the required purchasing tasks for the procurement of materials by following Standard Operating Procedures (SOP), and Work Instructions (WI)., • Submit approved Purchase Orders to suppliers for processing following supplier protocols for Purchase Order placement ensuring purchase requirements are met., • Resolve material shortages, discrepancies or other issues via communication with Suppliers to expedite procurement and researching alternate materials and Vendors., • Complete necessary tasks and assignments for NCMR’s, Process Deviations, and CAPA’s; participate in related QA meetings as required., • Create and maintain the part numbers in ERP software; create Purchasing Specifications for applicable part numbers ensuring minimum requirements are met., • Actively participate in Project Core Team meetings; collaborating with departments to ensure proper materials are procured; researching alternate materials, pricing and Vendors., • Communicate expectations to Suppliers, negotiate prices and terms, and recommend Suppliers with respect to cost, quality, and lead-time., • Negotiate/implement Supplier Agreements, Quotes and Change Notifications. Performs periodic review of Agreements, Quotes and Notifications to ensure they are accurate and active., • Meets with Suppliers to maintain positive business relationships; interact with suppliers to manage production and fulfillment schedules., • Compile and analyze data to perform price analysis, make source selection and procurement justifications., • Bachelor’s degree in finance, business administration, supply chain or other related field of study and, typically, 4+ years of applicable experience to include 2+ years with ISO 13485 or other similarly regulated industry. Equivalent combination of education and experience may be considered., • Applied experience in an ERP system; Oracle Cloud is highly advantageous., • Experience in Life Sciences, medical device industry, or other regulated environment is advantageous., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

Job Description Summary/objective For over 40 years, IABA has been providing high quality, person-centered treatment for children and their families. We take pride in the positive changes we make in our community. As a Behavior Interventionist with IABA, you will serve as a key member of our team, specializing in delivering evidence-based, person-centered interventions to support children with developmental disabilities like Autism Spectrum Disorder. In this role, you will have the opportunity to make a profound impact on the lives of children with disabilities by implementing personalized treatment plans, fostering skill development, and promoting positive behavior change. Your primary goal is to provide one-to-one intensive intervention, assisting clients in developing the skills necessary to be integrated into school and other community settings Using the principles of Applied Behavior Analysis (ABA), you will provide one-on-one support in the home and community, using our positive-only methods to reinforce desired behaviors, and enhance play, self-care, cognitive, social, and communication skills. Essential functions Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Duties: • Direct intervention with child/family, • Keep accurate client records, • Maintain accurate administrative records, • Drive between sites, • Attend/Participate in Training Competencies Administrative/Non-Clinical • Proficiency with Microsoft Office, including data entry in Microsoft Excel and Microsoft Word for purposes of recording data in digital logbooks., • Proficiency with web-based online learning platforms., • Able to simultaneously take accurate data while conducting discrete trials (80% data reliability as measured by supervisor observation)., • Able to implement behavior support plan as outlined in Behavior Intervention Plan and/or MEBS plan by implementing proactive and reactive strategies accurately (80% implementation reliability as measured by supervisor observation)., • Able to implement case-specific differential reinforcement procedures (DRO and DRA) for the duration of session (as measured by supervisor observation)., • Able to implement discrete trial teaching strategies according to SD-R-SR+ criteria (with 80% fidelity as measured by supervisor observation)., • Able to implement least-to-most prompting strategies (with 80% fidelity as measured by supervisor observation). No supervisory responsibilities Work environment While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, grasp or feel; reach with hands and arms; push and pull, and talk, hear and smell. The employee is occasionally required to stoop, kneel, or crouch. Employee in this position may encounter prolonged sitting and/or standing. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus Requirements Required education and experience • High school Diploma required, • Prior job-related experience with Applied Behavior Analysis working with children with autism or other developmentally delaying disorders (preferred), • Bachelor’s degree (preferred), • Must pass LIVESCAN (DOJ/FBI), provide DMV printout, Valid Driver's license proof of insurance, and current TB clearance. first aid and CPR training, • COVID-19 Vaccination Requirement:, • Where permitted by applicable law, new hires must have received the COVID-19 vaccine. The Company will consider reasonable accommodations to qualified employees with disabilities or for a sincerely held religious belief., • Affirmative Action/EEO statement, • It is the policy of IABA to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable, • Other duties • Competitive pay based on experience and ABA coursework, • Earned Paid Time Off/Vacation (for full-time employees), • Paid Sick Time, • Regular training, support, and mentorship from IABA Supervisors, • Health, Dental, and Vision insurance (for full-time employees), • Comprehensive paid training both when you are hired and ongoing, • Potential to receive BCBA supervision hours when enrolled in a qualified Master's program, • Paid Drive Time & Mileage, • Excellent opportunities for advancement, • Opportunities to earn rewards and recognition based on performance on clinical and administrative tasks, • Cell phone reimbursement

Job DescriptionSalary: 160,000 - 210,000 About Codera Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Site Director, Clinical Operations is responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Coderas clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, the Site Director, Clinical Operations will monitor and oversee site activities both onsite and remotely to ensure that patients rights, safety and well-being are protected and that the data generated at sites are complete and accurate. The Site Director, Clinical Operations will be accountable for patient enrollment and overall delivery of high-quality patient data in established timelines for all designated sites and/or assigned region. Essential Duties and Responsibilities Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines Develop and cultivate strong site relationships and ensure continuity of site relationships Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance Identify, assess, escalate and resolve site performance or quality issues in a timely manner Complete feasibility and site identification activities for new clinical studies Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments) Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance Responsible for the development of site specific recruitment, retention and follow-up plans Facilitate and support investigator site audits and/or inspection activities as needed Perform remote data review and query resolution for designated sites Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives Coach and mentor colleagues as needed Contribute to the review of Coderas systems and procedures as needed May be involved, when needed, in other areas of study management and staff training Execute other duties as assigned Qualifications Bachelors Degree in a Life Science discipline required Bachelors Degree in Nursing or RN a plus Minimum 3 years of direct site monitoring experience required Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle Detail-oriented, organized and committed to quality and consistency Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines Excellent team-interaction skills and ability to work successfully in team settings Ability to work in a dynamic environment with a high degree of flexibility Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs Excellent written and verbal communication skills Experience and proven proficiency in CTMS and eTMF systems preferred Must be willing and able to travel up to 50-65% While relocation is not required, the successful candidate must be able to travel frequently (5065%) to sites located in Washington (WA), Oregon (OR), California (CA), and Arizona (AZ). Proximity to a major airport and flexibility for multi-day travel are essential.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: The LVN assists with the conduct of clinical trials through dispensing investigational drugs, the collection of biological samples, performing venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor’s written orders. In executing these responsibilities, the Unit Clinician is guided by Good Clinical Practices (GCP). Responsibilities: • Dispense and collect investigational products, routine medications, and PRN medications while subjects are housed on the site observation unit as dictated by written orders., • Perform appropriate research protocol procedures which may include but are not limited to vital signs, blood collection and processing, ECGs, and point of care laboratory tests., • Perform basic lab procedures including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups., • Ensure that biological specimens are disposed of appropriately., • Maintain a clean, safe work environment., • Study, learn and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable., • Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives. Skills and Qualifications: • Education and experience, • Graduate / completion of approved accredited school of nursing. Education and requirements will be determined by the site’s need and protocol requirements., • Valid License as an LVN in the state of practice; maintain current license., • Must have a minimum of one (1) year of clinical experience., • CPR Certification required, ACLS preferred for LVN., • Phlebotomy certification (national) preferred., • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines., • Communicate with providers, co-workers, and others in a collaborative and courteous manner., • Knowledgeable in medical terminology to communicate with physician office and staff., • Requirements, • Ability to work independently and as a team player., • Ability to organize and prioritize within a changing environment., • Uses safety/universal precautions to protect self, subjects and staff., • Able to appropriately implement protocol and regulatory requirements in study conduct., • Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram., • Excellent documentation practices, • Good organizational and interpersonal skills, • Attentive to detail, good initiative and able to work with changing priorities.

Job DescriptionSalary: $75,000.00 - $100,000.00 We are a small, agile pharmaceutical company advancing late-stage small molecule assets in therapeutic areas with significant unmet need. As we prepare for pivotal clinical trials, we are seeking a highly experienced and detail-oriented Clinical Trial Material (CTM) Consultant to provide part-time, contract-based support for clinical supply strategy, execution, and comparator sourcing. The CTM Consultant will support activities related to the planning, sourcing, and management of clinical trial materials for late-stage development programs, including comparator sourcing and coordination with CDMOs, CROs, and depots. This part-time contract role is ideal for someone with deep experience in clinical supply operations who can operate independently and contribute strategic insight while managing hands-on tasks. ESSENTIAL DUTIES AND RESPONSIBILITIES • Develop and execute clinical supply plans for late-stage clinical trials, including forecasting, packaging, labeling, distribution, and return/reconciliation planning, • Identify and manage sourcing of commercial comparators for global clinical trials, including negotiating supply agreements and managing vendors, • Coordinate with internal teams, CDMOs, depots, and CROs to ensure timely availability and delivery of clinical supplies to trial sites, • Provide strategic input on supply chain design, including depot network selection, packaging configurations, and overage estimates, • Monitor inventory levels, expiry, and resupply needs throughout the trial lifecycle, • Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and all applicable regulatory requirements, • Support documentation, including SOPs, supply plans, shipping records, and reconciliation reports JOB QUALIFICATIONS Education, Certifications, Experience • Bachelors degree in a scientific or technical discipline; advanced degree preferred, • Minimum of 8+ years of experience in clinical supply management, preferably within late-stage development, • Proven experience sourcing and managing commercial comparator products for global trials, • Strong knowledge of GMP/GCP and clinical packaging, labeling, and distribution processes, • Experience working with external vendors, CMOs, and third-party logistics providers, • Comfortable operating in a small team and startup environment with limited infrastructure, • Highly organized, proactive, and self-directed with excellent problem-solving skills, • Experience with IRT systems and supply chain forecasting tools is a plus. SPECIAL WORKING CONDITIONS • Hybrid office environment - must be located in San Diego, • Domestic travel up to 10% may be necessary, • Department: Manufacturing, • Reports To: Director, Clinical Supply, • Position Type: Contract (30 hours a week)

Job DescriptionAssociate General Counsel Fully Remote | Fast-Growing Biotech/Pharma Company Compensation: $200,000 – $300,000 Base + More Join a mission-driven biotech company transforming the future of rare autoimmune disease treatment. We’re developing innovative therapies for patients who need them most—and we’re looking for a strategic legal partner to help guide our growth. About the Role We’re adding an Associate General Counsel to our dynamic legal team. Reporting directly to the General Counsel, you’ll be a key business partner across the company, providing practical legal advice, driving compliance initiatives, and ensuring that we move fast while staying grounded in ethics and integrity. This is an opportunity to do meaningful work at the intersection of science, law, and business—where your impact will be felt across patients, employees, and the broader healthcare community. What You’ll Do * Keep Us Compliant: Navigate the complex biotech regulatory landscape and ensure we’re ahead of the curve on evolving laws. * Strengthen Our Culture of Integrity: Develop and deliver engaging training on compliance topics—from our Code of Conduct to anti-bribery and anti-kickback rules—while continuously refining company policies. * Be a Deal-Maker: Draft, review, and negotiate critical agreements (clinical trial, licensing, manufacturing, research collaborations, vendor, and more). * Enable Commercial Success: Partner with the commercial team to review promotional materials, advertising, and other go-to-market initiatives. * Protect and Empower: Spot legal risks early, propose smart solutions, and balance business agility with compliance. * Collaborate Across Teams: Work side-by-side with colleagues in R&D, Regulatory Affairs, Quality, HR, Finance, and Commercial to deliver clear, actionable guidance. * Be a Trusted Advisor: Foster trust at every level of the organization, championing ethical business practices and sound judgment. What You’ll Bring * JD (or equivalent) with active bar membership in good standing. * 10+ years of legal experience in biotech, pharma, or life sciences (in-house or at a top firm advising clients in these sectors). * Deep knowledge of the regulations shaping the biotechnology industry. * Proven success drafting and negotiating complex agreements. * Familiarity with global privacy frameworks (e.g., GDPR). * A reputation for providing clear, business-oriented legal counsel in fast-moving environments. * Exceptional communication and relationship-building skills—you can talk science with scientists, strategy with executives, and compliance with employees. * Impeccable ethics, attention to detail, and the ability to juggle multiple priorities without losing focus. Why Join Us? This isn’t just another legal role. It’s a chance to help shape a high-growth biotech company as it brings life-changing medicines to market. You’ll work with passionate, driven colleagues in a collaborative environment where your voice matters and your work has a direct impact on patients’ lives. If this sounds like something you are interested in, apply today!

Job Description Faro Health aims to improve lives by helping life sciences companies answer complex clinical questions, simply, efficiently, and effectively. Our software platform is used to orchestrate complex clinical development with a single source of truth. It brings words, data, and teams together, empowering researchers to design more intelligent trials, master complexity, and reach milestones faster. The Senior DevOps Engineer is a key member of the development team who will be entrusted to manage the complexity of change and ensure sanity and stability through CI/CD automation. By managing infrastructure as code, you will create the foundation for building amazing and intuitive software for clinical trial designers. At the intersection of development and operations, this position will have responsibility for designing and building tools for Azure and AWS Cloud using advanced patterns for Zero-Trust security, container orchestration, and distributed microservice scaling for our cloud-based apps. Duties and Responsibilities • Build highly interactive, single-page React apps that can scale with both increased interaction complexity and volume., • Design, implement, and maintain deployments at scale, infrastructure, reliability, and scalability; then iterate and optimize continual improvements., • Manage always-available infrastructure, deployment pipelines, and platform tooling to eliminate downtime and improve the manageability of services and systems., • Collaborate with Software Engineering teams to architect and develop infrastructure and automated deployments for cloud-native SaaS applications., • Research and integrate new technologies and innovative solutions to continuously enhance platform functionality and performance. Qualifications • You possess significant hands-on experience in Continuous Integration and Continuous Delivery (CI/CD), with at least 5 years of experience in software engineering and DevOps., • You have demonstrable expertise in managing complex infrastructure for high-scale, cloud-based systems., • You thrive in a fast-moving, growth-minded startup environment and are adaptable to evolving requirements., • You have a thorough and current understanding of technologies and frameworks involved in building robust cloud-native applications., • Cloud Platform Mastery: Extensive experience with cloud-service providers like AWS, Azure, and/or Google Cloud. Mastery of at least one cloud provider is essential. Hands-on experience in managing cloud infrastructure as code through Terraform., • Containerization & Orchestration: Deep knowledge and hands-on experience with containerization and clustering technologies, including Docker, Kubernetes, HELM, and Istio., • CI/CD & Workflow Automation: Solid expertise in CI/CD tools such as GitHub Actions, Ansible, Jenkins, BitBucket Pipelines, Azure DevOps, and serverless architectures. Proven ability to design and implement robust workflow automation., • Streaming Technologies: Experience with streaming technologies such as Kafka, Event Hubs, and RabbitMQ., • Application Development Support: Experience in developing and supporting server-side rendered applications using Node.js and Python, including full-stack considerations for containerized applications., • Scripting: Proficiency in scripting languages, including Python, Bash, and PowerShell., • Familiarity with generative AI (LLMs) and ability to apply prompt engineering for DevOps automation (e.g., config generation, runbooks)., • Excellent problem-solving skills and ability to blend traditional DevOps practices with next-gen AI capabilities., • Data Presentation & Analytics: Experience in data presentation and analytics is a plus., • Self-motivated and able to work effectively with minimal supervision., • Willingness and ability to rapidly learn new technologies and embrace diverse assignments. Salary Salary range for this position is $155,000 to $192,000 per year. Individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training Equity In addition to this position’s salary (listed above), equity will be a major component of the total compensation for this position. We aim to offer higher-than-average equity compensation for a company of our size, and communicate equity amounts at the time of offer issuance. Benefits • Health Care Plan (Medical, Dental & Vision), • Retirement or Pension Plan, • Stock Option Plan, • Life Insurance (Basic), • Short Term and Long Term Disability, • Paid Time Off (Flexible Vacation Policy, Sick & Public Holidays), • Training & Development, • Work from Home, Office or Hybrid

Job DescriptionJoin the front lines of clinical research. Hawthorne Health brings trials directly to investigators and patients in their communities by combining innovative technology with compassionate medical professionals, and we invite experienced healthcare experts to grow their careers by becoming part of the Hawthorne Hero network. Our Heroes are capable, motivated, and diverse - more importantly, they are dedicated to improving patients’ lives and the future of medicine for humanity. Key Responsibilities: • Complete onboarding and training requirements to perform clinical trial visits, • Provide availability, confirm visit acceptance, communicate with clinical trial/program participant/patient, • Prepare for the clinical trial visit by gathering supplies and equipment, testing the equipment, verifying expiration dates and determining visit readiness, • Travel to location of clinical trial/program participant, • Perform clinical trial visit activities within Sonographer scope of practice such as (but not limited to):, • Conduct ultrasound examinations, including cardiac and vascular studies, according to established protocols., • Prepare and maintain ultrasound equipment, ensuring it is in proper working condition., • Explain procedures to patients, addressing any concerns to ensure comfort and cooperation., • Obtain and analyze patient history and clinical information to tailor ultrasound examinations effectively., • Document and maintain accurate records of examinations and findings., • Collaborate with physicians and healthcare team members to discuss findings and assist in diagnostic evaluations., • Adhere to safety protocols and infection control measures., • Stay current with advancements in ultrasound technology and techniques through ongoing education and training., • Perform screenings, • Questionaries, • Adverse Events Collection, • Perform post visit data uploads/submissions as required, • Communicate with project team for any issues with may arise or concerns during visit, • Ensure clinical trial visit is conducted according to ICH/GCP and accuracy of data collected during the visit Position Requirements: • Experienced Sonographer with Associate's degree in Diagnostic Medical Sonography or related field; Bachelor's degree preferred. Registered Diagnostic Medical Sonographer (RDMS) certification from the American Registry for Diagnostic Medical Sonography (ARDMS) or equivalent., • Experience and knowledge of working in clinical research trials preferred, • Attention to detail and highly organized, • Ability to prioritize and manage multiple tasks, • Excellent verbal and written communication skills in English and the ability to complete detailed data, • Ability to work independently and as part of a wider team, • Technology savvy, • Ability to travel locally or across states lines based on licensure Location: This position requires Sonographers travel to the location of the study/program participant/patient. Travel may be local or across state lines based on licensure to practice. Apply directly at .

Job DescriptionSalary: $150,000 - $175,000 About Codera Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Associate Director, Clinical Trial Operations is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical operations and monitoring, inspection readiness and IRB/EC submissions of Coderas clinical trials according to Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. The Associate Director, Clinical Trial Operations will interface with Site Directors and the study team to support operational aspects of study start-up and execution. Essential Duties and Responsibilities • Support the execution of Phase I-IV studies including study start-up, site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s) and applicable study plans, • Prepare and manage potential investigator site lists, assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions, • Communicate with investigators and site staff on issues related to feasibility, essential document collection and local IRB/EC submissions., • Support study start-up activities including the facilitation of site selection internal approvals, review of and facilitation of ICF internal approvals and essential document approvals for IP release, • Prepare and review study documents (e.g., essential document packets, study plans, site Informed Consent Forms (ICFs), etc.) to ensure quality and consistency, • Support study start-up by performing primary or secondary reviews of Essential Document Packages and completing Investigator background checks, • Assist with development and distribution of study materials (e.g. ISF binder), tools and documents, • Responsible for oversight of the central IRB/EC, • Prepare and submit required study documents to central IRB/EC, • Support central IRB/EC annual reviews and study updates, • Communicate with central IRB/EC as needed, • Support site and local IRB/EC annual reports and updates, as needed, • Assist with the facilitation of the site contract and budget process, • Manage translation of necessary documents through translation vendor, • Support creation of and updates to study translation plan, • Support setup and management of Clinical Operations vendors (e.g. rater training, home healthcare)., • Facilitate and track vendor system access requests., • Assist in Clinical Trial Management System (CTMS) maintenance including entry of study and site level updates, assistance with running reports and reviewing CTMS entry accuracy, • Review study documents received from the study team for completeness and accuracy and upload to the Trial Master File (TMF), • Assist with TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times., • Assist with development and management of ancillary study site supplies such as ISF binders, patient facing materials, patient welcome kits or study related site materials, • Assist with oversight of study site training, • Support inspection preparedness and study/site audit and/or inspection activities, as needed, • Execute other duties as assigned Qualifications • Bachelors Degree with minimum 5 years of relevant clinical trial experience required, • Experience with feasibility and study start-up, • Experience and proven proficiency in CTMS and eTMF systems, • Experience with Veeva Systems preferred, • General knowledge of clinical site monitoring, feasibility and study start-up preferred, • Detail-oriented, organized, and committed to quality and consistency, • Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines, • Excellent team-interaction skills and ability to work successfully in global team settings, • Ability to work in a dynamic environment with a high degree of flexibility, • Possess a willingness and ability to work hands-on and with a sense of urgency in a fast-paced, entrepreneurial environment, • Must be proficient in Microsoft Word, Excel, and PowerPoint Codera, LLC is an equal opportunity Employer. Codera, LLC is a an E-Verify employer.

Job Description Role: Head of Regulatory Affairs Key Responsibilities: The Head of Regulatory Affairs is a key member of the leadership team, providing expert regulatory guidance and leadership for all development programs. This role is responsible for defining, developing, and implementing global regulatory strategies that support the company's product pipeline from preclinical research through clinical development and eventual market authorization. Essential functions and responsibilities Regulatory strategy and leadership • Develop and implement innovative global regulatory strategies for the company's product pipeline, ensuring alignment with corporate objectives., • Build a network of key regulatory strategic advisors to address specific questions, • Provide tactical and strategic regulatory guidance to cross-functional teams, including R&D, clinical development, manufacturing (CMC), and commercial operations., • Serve as the primary liaison with regulatory authorities, such as the FDA, EMA, and other international agencies. This includes leading interactions and negotiations throughout the product development lifecycle., • Oversee the preparation, submission, and maintenance of all critical global regulatory filings. This includes Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biologics License Applications (BLAs), and other relevant submissions., • Ensure timely and high-quality preparation of all regulatory documents, including meeting packages, briefing books, and annual reports., • Interpret and apply evolving regulations and guidance documents, communicating any impact on ongoing projects or future development plans to company leadership., • Build, lead, and mentor a small team of internal regulatory professionals and manage external consultants and vendors as needed., • Education: A Bachelor's degree in a relevant scientific discipline is required; an advanced degree (M.S., Pharm.D., or Ph.D.) is preferred., • Experience:, • Typically requires 10–15 years of progressively responsible experience in regulatory affairs within the biotech or pharmaceutical industry, with significant experience in developing new clinical assets., • Minimum of 5–8 years of experience in a leadership role within regulatory affairs is often required., • Proven track record of success in leading regulatory submissions and securing approvals from agencies such as the FDA., • Skills:, • Deep knowledge of global regulations and requirements, including ICH, FDA, EMA, and other relevant guidelines., • Hands-on experience with biologics and/or small molecule drug development., • Exceptional written and verbal communication skills., • Strong leadership, negotiation, and problem-solving abilities., • Ability to work effectively in a fast-paced, entrepreneurial environment Protego offers competitive benefits including medical, dental, vision, employer paid life and long-term disability insurance, 401(k) match, PTO and federal holidays.

Job Description We are seeking a highly motivated and qualified individual to join our Clinical Department as a Senior Statistical Programmer and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The Senior Statistical Programmer will serve as the lead statistical programmer and is responsible for statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting statistical analyses. This position requires close collaboration with cross-functional teams to ensure the integrity and accuracy of clinical data used in regulatory filings and internal reporting. Essential Responsibilities: • Acts as lead programmer for assigned studies., • Independently develop, validate, document and troubleshoot SAS programs for the preparation of periodic internal reports, regulatory submissions, and ad hoc analyses., • Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance., • Design, develop, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner., • Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies,, • Communicate with team members about statistical programming related to trial timelines, data quality, and results interpretation., • Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality., • Create SAS macros or other tools to enhance the efficient delivery of statistical services, providing associated documentation and staff training as needed., • Program quality checks for clinical study raw data and report findings., • Review or author SDTM and ADaM specifications and datasets., • Manage CROs, including reviewing or validating statistical deliverables of vendors., • Provides input in the design and development of case report forms., • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Bachelor’s degree in Biostatistics, Mathematics, Statistics, Computer Science, or related field, • Minimum 6 years’ experience in bio-pharma statistical programming, • Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures, • Strong expertise in CDISC including SDTM, ADaM, and CDASH, • Extensive experience in SAS macro functions and dynamic code generations., • Experience in regulatory submissions (e.g., NDAs and DSURs), • High attention to detail, with a focus on quality and traceability in all deliverables, • Strong interpersonal and teamwork skills with a collaborative mindset and the ability to manage multiple priorities in a fast-paced and dynamic environment with shifting timelines and evolving needs, • Take initiatives to solve problems proactively and think critically, • Willing to adapt to changing business needs, able to pivot between tasks, • Able to make complex programming and data-related decisions independently, • Comprehensive knowledge and deep understanding of statistical programming environments, processes, procedures, and roles for clinical development from Phase 1 through regulatory submission, • Experience in R is strongly preferred, • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Strong problem-solving skills and a proactive attitude towards exploring different approaches, • Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams, • Must be able to work independently with supervision as needed, • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively and collaboratively in a dynamic and fast-paced environment, • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team. Position Summary We are seeking a detail-oriented and proactive Clinical Research Associate to monitor clinical study data and ensure the integrity and quality of research processes. The CRA will play a key role in supporting our Quality Assurance team by verifying data accuracy, compliance with study protocols, and regulatory requirements. Additionally, the CRA will assist in handling external monitoring visits to ensure smooth and compliant site audits. This position requires minimal travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is non-exempt (hourly) and full-time, working 40 hours per week, Monday through Friday. Key Responsibilities • Monitor and review clinical study data for accuracy, completeness, and consistency throughout the study lifecycle., • Conduct site visits (remote or on-site) to review source documents, case report forms (CRFs), and other study documentation., • Assist in handling and coordinating external monitoring visits, including preparation, communication, and follow-up., • Collaborate with site staff and internal teams to resolve data discrepancies and ensure timely data entry., • Support the implementation and maintenance of quality assurance standards for clinical trials., • Assist in audit preparation and support regulatory inspections as needed., • Document monitoring activities in accordance with company SOPs and Good Clinical Practice (GCP) guidelines., • Contribute to continuous improvement initiatives to enhance data quality and compliance processes., • Additional duties as assigned.Skills & Qualifications, • Education: Bachelor's degree in life sciences, healthcare, or related field., • Experience: Minimum of 5 years in clinical research monitoring or data management preferred., • Skills & Abilities:, • Strong understanding of GCP, ICH guidelines, and clinical trial processes., • Excellent attention to detail and organizational skills., • Ability to communicate effectively with cross-functional teams and site staff., • Proficiency in CTMS, EDC systems, and Microsoft Office Suite., • Analytical mindset with problem-solving skills., • Ability to prioritize tasks and manage time effectively. Physical Requirements Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable. What We Offer • Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities, • In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay, • Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network) California Consumer Privacy Act (CCPA) Notice Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

Job Description ESSENTIAL DUTIES AND RESPONSIBILITIES: • Receive, review, and verify prescription orders from the Principal Investigator to ensure study validity., • Prepare and dispense medications accurately in accordance with physician orders and study protocols., • Support pharmacological services by stocking, assembling, and labeling investigational products., • Assist clinical research staff by addressing inquiries and referring complex issues to the Principal Investigator or Pharmacist as needed., • Maintain accurate pharmacy inventory records to support smooth clinical trial operations., • Ensure a sterile and compliant environment for medication preparation and dispensing., • Follow security measures and quality control protocols to maintain the integrity of investigational products., • Meet all study protocol requirements and deadlines, ensuring compliance with Good Clinical Practice (GCP) guidelines., • Adhere to all company policies, protocols, and regulatory compliance standards to maintain confidentiality and integrity., • Perform other duties as assigned to support the success of clinical research operations. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPREIENCE: • High school diploma or GED required; pharmacy technician certification (CPhT) preferred., • Prior experience in a pharmacy, clinical research, or healthcare setting is highly desirable., • Knowledge of pharmacy information systems, prescription processing, and regulatory guidelines related to investigational products., • 401 (k) Retirement Plan, • Medical, Dental, and Vision Insurance, • Paid Time Off (PTO), • Floating Holidays, • And more!

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Business Development Director in San Diego, CA. The Business Development Director will be responsible for expanding Invivoscribe’s global partnerships across pharma, biotech, and diagnostics, driving strategic alliances that accelerate the adoption of our assays, services, and emerging offerings in next-generation sequencing (NGS), whole genome sequencing (WGS), and measurable residual disease (MRD) testing. S/he will serve as a key commercial leader - identifying, shaping, and closing high-value opportunities that advance Invivoscribe’s mission and market leadership in precision medicine. Core Responsibilities Include: Strategic Partnership Development • Identify, evaluate, and pursue new business opportunities across biotech, pharma, and life sciences sectors., • Develop and execute strategies to grow partnerships with key stakeholders, including pharmaceutical companies, academic institutions, and research organizations., • Ensure partnerships strengthen Invivoscribe’s differentiation, competitiveness, and market leadership., • Build and maintain a strong pipeline of qualified leads and opportunities, converting them into long-term revenue-generating relationships., • Lead negotiations for fee-for-service, custom development, licensing, and strategic collaboration agreements., • Take the lead in high-stakes negotiations and alliance management, ensuring win–win outcomes and strong partnership governance., • Conduct market research and competitive analysis to identify emerging trends, customer needs, and partnership opportunities., • Develop data-driven business cases and strategic recommendations for senior leadership., • Expand partnerships in companion diagnostics (CDx) and clinical services to drive growth and innovation., • Accelerate adoption of Invivoscribe assays into international cancer care guidelines and pathways., • Build collaborations with global KOLs that strengthen scientific credibility and commercial traction., • Drive revenue targets and partnership outcomes that align with Invivoscribe’s strategic objectives., • Deliver measurable growth through a robust and sustainable business development pipeline., • Bachelor’s degree in Life Sciences, Biotechnology, Business, or other related field of study and, typically, 10+ years of business development experience in biotech, pharma, or life sciences, with a strong track record of closing deals and building partnerships. Advanced degree is advantageous. Equivalent combination of academics and experience will be considered., • Networked with strong relationships in pharma, biotech and/or diagnostics to accelerate partnerships., • Proven ability to navigate complex deal structures; companion diagnostics, licensing, collaborations., • Solid understanding of drug development, molecular diagnostics, or biotechnology platforms., • Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint) and the ability to learn new software programs. Able to utilize collaboration tools such as MS Teams, Webex, zoom and other virtual platforms. We Bring: • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

Job DescriptionDescription: At Kumquat, our mission is to bring meaningful medicines to patients through science, efficiency, and innovation. The Medical Director is a key partner in this effort—guiding the development of study drugs, shaping thoughtful clinical trial designs, and working closely with study teams to deliver high-quality trials that truly serve patients. We invite you to join our mission and become part of a passionate, collaborative community. We believe in shared accountability and in the potential of every team member to learn, grow, and achieve more than what’s defined in a job description. The Medical Director will report to the SVP of Clinical Development and lead a cross-functional team for one or more study drugs by: • Providing general clinical and strategic input to senior management., • Collaborating closely with preclinical and drug discovery teams to exchange insights, providing clinical expertise and guidance on the development and clinical advancement of new molecules., • Designing clinical development plans., • Lead or contribute, as applicable, to the development and review of all study conduct-related documents, ensuring they are accurate, clear, and aligned with protocol and regulatory standards., • Leading engagement with regulatory authorities in a clinical capacity, representing the company as a medical expert in meetings, briefings, and official communications., • Actively contributing to study and site start-up activities., • Overseeing and executing clinical studies for one or more drugs, ensuring accountability for their successful conduct in alignment with the clinical development plan., • Interpreting clinical data from ongoing studies, ensuring accurate analysis and providing medical insight to guide study conduct and decision-making., • Proactively engaging and building strong relationships with key opinion leaders and clinical investigators., • Acting as a proactive partner to external stakeholders across multiple countries, providing support for local needs and priorities., • Stay current on emerging treatments and developments relevant to the company’s interests and study-specific therapeutic areas., • Cultivating meaningful peer-to-peer collaborations and nurturing a culture of curiosity to enable faster, simpler, and more patient-centric ways of operationalizing our studies., • Working with colleagues across Kumquat to promote communication and community., • A talented and passionate professional, inspired by our shared purpose to innovate clinical trial delivery and bring better medicines to more patients., • Comfortable thriving in environments of ambiguity and collaboration, making sound decisions quickly while seeking advice when needed., • Skilled in organizing and problem-solving to run efficient teams., • An effective communicator, sharing information transparently and strategically., • Comfortable working openly and actively listening to colleagues., • Experienced in leading or being an active member of large or small, diverse teams., • Collaborative and humble, valuing team input, continuous learning, and shared success while contributing expertise and guidance. Expectations: • Knowledge of clinical development, including study design, protocol execution, and drug development—especially early-phase clinical development., • Provides subject matter expertise by supporting the design and execution of clinical trials and/or enabling projects across geographies., • Independently develop plans, with minimal guidance, to support the design and execution of clinical trials and/or enabling projects., • Applies proficient knowledge of, and ensures adherence to, ICH, GCP, and regulatory guidelines within clinical trials or enabling activities., • Participates in identifying vendors, building relationships with sites and investigators, and partnering to ensure the execution of clinical trials., • Works closely with investigators and clinical site staff. Requirements: • MD or MD/PhD with oncology and/or hematology expertise., • At least 3 years of relevant experience in early development within the pharmaceutical or biotech industry., • Phase 1 trial experience in solid tumors or hematologic malignancies, with a preferred focus on small molecules., • Working knowledge of drug development and clinical development activities and deliverables., • Ability to solve complex problems, take new perspectives on existing solutions, and exercise judgment based on analyzing multiple sources of information., • Ability to explain complex information clearly and effectively.

Job Description At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn’t have to be a tech expert or a math genius to take charge of your health. Please note: This is an on-site position based in San Diego, CA with up to 50% travel. This role is not eligible for relocation assistance. The Clinical Study Manager’s responsibilities include, but may not be limited to the following: Role and Responsibilities: • Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budget, • Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents., • Develop clinical study reports for submission to regulatory authorities., • Oversee and review deliverables produced by study team members to ensure quality and compliance., • Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work., • Ensure that studies comply with MMI policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations., • Develop and implement standardized processes and operating procedures for conducting clinical research., • Create and maintain clinical study documents as part of the trial master file (TMF)., • Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants., • Conduct on-site clinical monitoring activities as needed., • Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)., • Support the submission of FDA Investigational Device Exemption (IDE) applications, including drafting clinical protocols, investigator brochures, and IDE summary reports., • Maintain and update the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with EU MDR, ensuring integration of clinical data, risk-benefit analysis, and PMS findings., • Design and execute Post-Market Clinical Follow-up (PMCF) activities, including studies, surveys, and literature reviews, to support ongoing safety and performance of Modular Medical products., • BA/BS degree in Health or Life Sciences required, advanced degree preferred., • Five (5) or more years of experience in Clinical Research., • Three (3) or more years of experience managing medical device and/or combination products clinical research studies., • Experience in the diabetes industry preferred., • Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans., • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies., • The ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded., • Ability to handle multiple tasks while ensuring timely and accurate completion • Ability to sit or stand for extended periods of time, • Ability to lift and/or move up to 35 pounds

Job DescriptionDescription: At Kumquat, we strive to transform cancer treatment to achieve durable therapeutic benefits and a renewed sense of hope to patients. The Corporate Counsel is a key member of the Legal Team who reports directly to the General Counsel and plays an integral role in the development, negotiation, and execution of company contracts across all departments. The Corporate Counsel drafts and negotiates clinical, IT, research & development, quality, and other legal agreements that support Kumquat’s business objectives, minimizes risk, and ensures compliance with company standards. We want you to join our team and be part of our passionate and collaborative community. We value individual and team accountability and also see the potential of all our people to learn and grow. Job Responsibilities • Draft, review, analyze, and negotiate clinical related contracts, including clinical trial agreements (CTAs) and ancillary agreements (including SCCs, LOIs, DRAs, LRAs), informed consent forms (ICFs), master service agreements and related work orders, vendor and service contracts, IT agreements, consulting agreements, and confidential disclosure agreements, • Liaise and effectively communicate with with key stakeholders including external parties, internal business units, and contract research organizations (CROs), • Assist General Counsel with ad hoc legal projects as neededRequirements:, • Juris Doctor degree required and 5+ years of in-house pharmaceutical or biotechnology contract/legal experience, • Proficient clinical contract drafting and negotiation skills, • Knowledgeable about statues, regulations, and industry guidelines impacting pharmaceutical research and development and clinical trials including data privacy, • Highly responsive, team-work oriented, and meticulous attention to detail, • Excellent verbal and written communication skills

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Senior Business Systems Analyst (ERP) to join our Information Technology team. We will consider a consultant, or contract to hire. The Senior Business Systems Analyst (ERP) serves as an internal subject matter expert and technical lead for Invivoscribe’s Oracle Fusion ERP system, with particular focus on the Finance, Supply Chain, and Project Management modules. This role drives process improvement and provides technical expertise, process analysis, reporting support, vendor management, and cross-functional coordination to help maximize the value of the ERP platform and align with evolving business needs. Working closely with functional stakeholders, IT leadership, and vendor partners, the Senior Business Systems Analyst (ERP) will support ERP configurations, reporting, user management, quarterly system upgrades, and ongoing system enhancements. Core Responsibilities Include: • Serve as primary technical expert for Oracle Fusion ERP support, configuration, reporting, and system health., • Analyze business needs and translate them into documented technical requirements, configurations, and reports/dashboards within Oracle Fusion ERP., • Serve as a key leader in coordinating quarterly Oracle Fusion ERP upgrade cycles and system enhancements, driving risk assessments of vendor-provided changes, guiding testing and validation activities, and contributing to change control documentation efforts in collaboration with cross-functional teams., • Ensure ERP changes and enhancements are aligned with regulatory requirements and internal validation procedures, contributing to audit readiness., • Provide internal front-line support for ERP issues raised from ERP Analysts and business users and manage escalation of complex issues to outside third-party support, as needed., • Collaborate with functional departments to proactively identify opportunities for process optimization and lead initiatives to streamline ERP workflows and business processes across Finance, Supply Chain, and Operations., • Build and maintain reporting solutions including standard reports, ad hoc queries, dashboards, and KPI monitoring., • Support data integrity, user access governance, and compliance with applicable internal controls and quality standards., • Participate in data migration, system integration, and system validation activities as needed., • Mentor and provide technical guidance to junior ERP analysts and power users., • Create and maintain technical documentation, process flows, and training materials., • Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field of study and, typically, 5+ years of relevant experience supporting ERP systems in a business systems, functional analyst, or technical lead role. Knowledge of regulated environments (e.g., ISO 13485, QSR) is advantageous., • Experience with Oracle Fusion ERP is highly preferred; experience with other major ERP platforms (e.g., NetSuite, SAP, Workday) will be considered with strong transferable skills., • Advanced functional knowledge of Finance, Supply Chain, and/or Project Management modules., • Solid understanding of ERP architecture, data structures, reporting tools, and integration points., • Hands-on experience with query tools (e.g., SQL, BI tools) and report development., • Experience participating in ERP implementations, upgrades, and/or major enhancement projects., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

Job DescriptionDescription: REPORTS TO Chief Operating Officer JOB DESCRIPTION/SUMMARY The Senior Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. This position is responsible for primary authorship and supporting CMC regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications. ESSENTIAL DUTIES AND RESPONSIBILITIES The main Regulatory Affairs responsibilities of this role include but are not limited to the following: • Serves as the regulatory lead on CMC development teams, providing guidance and oversight., • Manages administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time., • Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings., • Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed., • Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs., • Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams., • Collaborates with and supervises contributions from contractors and vendors., • Develops and manages project timelines for regulatory submissions., • Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments., • Bachelor's degree in scientific discipline with at least 5 years of experience in CMC Regulatory Affairs., • Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs, • Deep understanding of global regulatory frameworks and evolving guidelines, • Ability to lead in a fast-paced, collaborative environment with shifting priorities, • Strategic mindset with a hands-on approach to problem-solving and execution, • Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD., • Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle., • Working knowledge of FDA and ICH regulatory guidance and regulations., • High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom, • High attention to detail and excellent proofreading and editing skills, • Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion, • Ability to multi-task, professional demeanor, strong attention to detail, • Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude, • Must be dependable; someone willing to go the extra-mile to get things done Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job DescriptionSalary: $210,000 to $220,000 Who Are We? Founded in 1997 and built upon 27+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diegos Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. Who Are You? You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently. What is the Primary Objective of the Executive Director, Clinical Operations? Reporting to the Senior Vice President of Clinical Development, the Executive Director of Clinical Operations is responsible for oversight of the overall clinical operations strategy, execution and management of clinical studies. Your Main Responsibilities and Duties Include: • You will be responsible for driving and leading the successful execution of all operational components of the Companys clinical programs utilizing strong project management, leadership, and organizational skills; partnering with internal and external stakeholders to drive robust data-driven decisions., • You will be accountable for operational execution and strategy across multiple clinical programs, including developing and executing study plans, driving efficient start-up activities and study recruitment, and trial site management., • You will lead the development and continuous improvement of SOPs, functional systems, processes, tools relevant to the Clinical Development organization and adherence to established laws, regulations, and guidelines., • Key activities include strategy and planning towards milestones, managing the supporting clinical operations team, hands-on management of external vendors, driving critical path activities, proactively identifying issues and resolving conflicts., • Additionally, you will be responsible for programmatic resource and financial planning / forecasting and budget management., • You will collaborate with internal and external stakeholders to ensure strategic alignment of objectives, develop operational strategy, and execute clinical programs on time and within budget., • You will review and approve study-related materials including protocols, informed consent forms, monitoring plans, site training materials, EDC/case report forms, study, lab and pharmacy manuals, data management plans, monitoring reports, etc. as needed., • You will oversee study-related activities including site identification and selection, enrollment models, clinical supply planning and drug supply, lab kits, investigator and vendor meetings, development of systems, review of data during the study, data cleaning, database lock, etc., • You will proactively identify project risks before they arise and develops contingency plans; escalate issues related to quality, timelines, and budget and provide recommendations., • You will collaborate with legal and finance (and others as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, contract negotiation and development, clinical trial agreements, payment terms, milestones, etc.), • You will directly mentor, coach and develop senior level clinical operations staff. To Succeed in this Position: • You should have at least 15 years of experience working in a clinical operations role, with at least 8 years in study management. At least 5-7 years in direct people management is preferred. Experience working in dermatology or ophthalmology drug development ideal but not required., • You should have at least 10 years of experience with monitoring of budget and progressive clinical trial management across the full-cycle of drug/device development (e.g. Phase 1 through Phase 4, etc.). Solid understanding of drug/device development is required., • You should have a proven track record of leadership and success at the Senior Director level., • You should have a good project management and organizational skills, attention to detail and time-management., • You should have a good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies., • You should have excellent verbal and written communication skills., • You should be a team player who is willing to roll up your sleeves to get the job done. Please note this is a San Diego based position. Candidates will be required to be onsite per our Company's hybrid schedule. We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.If you are smart and good at what you do, we welcome you to apply!

Job DescriptionAbout Us Modena Health ("MH") and Modena Allergy & Asthma ("MAA") are leading and rapidly growing medical practices specializing in allergy, asthma, and immunology care, with clinics across Southern California and Arizona—and ambitious plans for national expansion. We are physician-led, hospitality-focused, and technology-enabled, committed to transforming allergy care while advancing clinical research and expanding access to cutting-edge medicine. Known for our high standard of excellence, we provide compassionate, patient-centered care for both pediatric and adult patients. Our model combines hospitality-driven service with innovative technology solutions that streamline operations, improve clinical outcomes, and enhance the experience for both patients and providers. At Modena, we aim to hire great people, treat them well, and help them find meaning and purpose in our mission. Our dedicated team values collaboration, positivity, and growth while striving to improve lives through expert diagnosis, treatment, and research. We are looking for high-energy, kind, and collaborative individuals eager to grow personally and professionally while making a meaningful impact in the lives of others. Position Summary We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join our growing practice in Greater San Diego, Greater South Bay LA, & New Prospect Locations. As a key member of our healthcare team, you will be responsible for diagnosing and treating patients with a wide range of allergic and immunologic conditions. You will provide high-quality care, collaborate with other medical professionals, and have the opportunity to work in a patient-centered, multidisciplinary environment. The ideal candidate must be a self-motivated and eager individual who will establish him/herself in a practice that enjoys continuous growth. Must have excellent communication skills, bedside manner, and a strong work ethic with a desire to be part of a team that is committed to caring for the whole patient. We place special emphasis on providing patient-centered care, quality outcomes and patient satisfaction. If you are a dedicated and caring Allergist/Immunologist with an interest in advancing the field through clinical research and looking to make a difference in the lives of patients, we encourage you to apply. This is a unique opportunity to shape the future of allergy and immunology care while contributing to groundbreaking research in a collaborative and supportive environment. This role is exempt (salary) and full-time, working 40 hours per week, Monday through Friday with minimal travel. Key Responsibilities • Clinical Responsibilities, • Diagnose, treat, and manage patients with allergies, asthma, immunologic conditions, and related diseases., • Conduct comprehensive patient evaluations, including medical history, physical exams, and appropriate diagnostic tests (e.g., skin tests, blood tests, pulmonary function tests)., • Develop and implement individualized treatment plans, including medication management, immunotherapy, and lifestyle modifications., • Educate patients and their families about managing allergies, asthma, and immunologic conditions., • Perform procedures such as allergy skin testing, spirometry, and immunotherapy (allergy shots)., • Oversee in-office oral food challenges, drug challenges, and immunotherapy treatments (oral immunotherapy and sublingual immunotherapy for environmental and food allergy), • Develop and implement individualized care plans based on patient needs and medical history, including:, • Starting allergy immunotherapy for environmental allergies, • Starting oral immunotherapy for food allergy, • Recommending food or drug challenges as part of allergy evaluation, • Collaborate with other specialists (e.g., pulmonologists, dermatologists, primary care physicians) to ensure comprehensive care for patients., • Maintain accurate and up-to-date medical records in compliance with healthcare regulations and confidentiality standards., • Stay informed about the latest advancements in allergy and immunology treatments and participate in continuing medical education (CME)., • Ensure high patient satisfaction and provide empathetic care, focusing on patient education and wellness., • Additional duties as assigned., • Research Responsibilities, • Engage in clinical research initiatives through Orso Health, Modena Health's research arm, related to the diagnosis, treatment, and prevention of allergic and immunologic diseases, or other areas of clinical interest., • Participate in designing and conducting clinical trials, including trials on new therapies, biologic treatments, and immunotherapy options., • Analyze data, prepare research reports, and collaborate with research teams to publish findings in medical journals., • Contribute to the development of innovative clinical pathways and treatment strategies based on research findings., • Work closely with industry partners, academic institutions, and research foundations to advance clinical studies in allergy and immunology., • Provide mentorship and guidance to junior researchers interested in allergy and immunology research., • Present research findings at national and international conferences., • Additional duties as assigned.Qualifications & Requirements, • Education, • Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree from an accredited medical school., • Experience, • Completion of an accredited residency in Internal Medicine or Pediatrics., • Successful completion of a fellowship in Allergy and Immunology., • Board certified or board eligible in Allergy and Immunology., • 1–3 years of post-fellowship clinical experience preferred; will consider highly qualified new fellowship graduates., • Demonstrated experience in diagnosing and managing patients with allergies, asthma, and immunologic conditions., • Hands-on experience performing and interpreting allergy testing, spirometry, and administering immunotherapy, • Licensure & Certifications, • Board certification or eligibility in Allergy and Immunology (ABAI)., • Valid and unrestricted medical license to practice in California., • Skills & Abilities, • Strong knowledge of allergy, asthma, and immunologic diseases and treatments., • Interest and experience in clinical research, including trial design and data analysis., • Excellent communication and interpersonal skills, with the ability to build rapport with patients and their families., • Ability to work effectively both independently and as part of a collaborative healthcare team., • Compassionate and patient-centered approach to care., • Preferred Qualifications, • Experience in a clinical or private practice setting., • Bilingual in Spanish (preferred but not required)., • Expertise in immunotherapy and biologic treatments for allergy and asthma., • Experience in writing research protocols, grant submissions, or publishing research., • Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities, • In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay, • Opportunity to shape the future of a thriving allergy and asthma practice in beautiful San Diego (and across our expanding network) California Consumer Privacy Act (CCPA) Notice Modena Health ("MH") and Modena Allergy & Asthma ("MAA") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. The Director or Senior Director, Safety Science will provide safety science and pharmacovigilance support to molecules across the Erasca portfolio. The position will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development portfolio. They will bring safety expertise to interactions with internal stakeholders and regulatory authorities and must have the ability to interact effectively in a multifunctional and multicultural team setting. Additionally, the Director or Sr Director, Safety Science will work closely with Safety Operations for case review, medical review, and study oversight for patient safety. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Develop and maintain an understanding of the safety profile of assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)., • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy aligned with clinical development plan(s)., • Provide medical review of cases inclusive of case narratives and causality assessments of AE/SAE reports., • Contribute to the drafting of safety assessments and drug safety reports for individual cases or aggregate data for signals or in response to Regulatory Authority requests., • Responsible for signal detection and management activities including, but not limited to, ISMP maintenance., • Responsible for the preparation and maintenance of safety sections of the ISMP, DSUR, IND Annual reports and/or Reference Safety Information in the IB., • Contribute to regulatory authority submissions and provide medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties., • Represent Medical Drug Safety in communication with health and regulatory authorities and at independent Data Safety Monitoring Committee meetings., • Evaluate risk minimization strategies and take accountability for the medical-scientific content in Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant., • Review clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication., • Present important safety issues to program teams for internal and external review., • Serve as safety science representative for clinical trial team meetings or investigator/site meetings., • May support non-molecule projects, due diligence evaluations, and other projects as needed., • Responsible for coordination and collaboration with vendors servicing Safety Science., • Accountable for the safety components of study reports, publications, aggregate reports, and high-level regulatory documents., • Healthcare professional degree required. MD or PharmD highly preferred, other relevant clinical degrees may be considered., • 6 or more years of drug development experience in the pharmaceutical or related industry including at least 4 years in drug safety for oncology clinical development., • Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management is essential., • Expert knowledge of regulations governing pharmacovigilance., • Exposure to Safety Operations and experience with data entry and administration of drug safety databases, such as Oracle Argus, a plus., • In depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation; exposure to early clinical development preferred., • Experience interacting with regulatory authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums required; filing experience highly preferred., • Strong presentation skills, effective at summarizing and presenting key considerations and decision points., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job DescriptionCompany Overview:We are a clinical-stage biopharmaceutical organization dedicated to discovering and developing innovative oral therapies for various medical indications with significant unmet needs. Our focus is on targeting biological pathways associated with specific clinical challenges to positively influence disease progression. Our pipeline features multiple programs across diverse therapeutic areas, including those related to pulmonary and fibrotic disorders. Job Summary:The Director of Clinical Data Management will play a crucial role in supporting Clinical Operations and Biometrics by ensuring the completeness, accuracy, and consistency of clinical data. This position involves overseeing clinical data management activities performed by Contract Research Organizations (CROs), conducting detailed data reviews, and collaborating with cross-functional teams to meet project goals and timelines. Key Responsibilities: • Participate in the selection process for CROs involved in data management activities, including proposal reviews and bid defenses., • Oversee CRO clinical data management activities for assigned clinical studies., • Manage user permissions and access for all clinical study-related platforms., • Review and provide feedback on data management and study documentation, including data management plans, study protocols, data transfer agreements, and validation specifications., • Ensure that case report forms are designed in accordance with study protocols and other relevant documentation., • Supervise the electronic data capture database build process, including the review of specifications and validation documents. Participate in user acceptance testing of various data systems during initial builds and subsequent updates., • Conduct thorough reviews of clinical trial data as required., • Represent the Clinical Data Management function in relevant internal and external meetings., • Ensure the timely delivery of project milestones and manage CRO performance accordingly., • Communicate the status of clinical trials, including milestones and deliverables, throughout the study duration., • Contribute to improvement initiatives within the Clinical Data Management department. Assist in the development and implementation of new technologies and tools. Create standard operating procedures and templates., • Supervise clinical data management activities and engage in direct negotiations with CROs regarding timelines and quality issues., • Support clinical data medical reviews., • Escalate unresolved data or compliance issues to relevant managers and work collaboratively with CRO data managers, partners, vendors, and internal teams to resolve them., • Bachelor’s degree from an accredited institution in a relevant field such as Life Sciences or Computer Science, or equivalent practical experience., • 10-15+ years of experience in Clinical Data Management within the biopharmaceutical or biotechnology industry, with a strong understanding of clinical drug development processes. Experience with NDA submissions is a plus., • In-depth knowledge of relevant data management systems and industry standards., • Detail-oriented, communicative, and accountable, with strong verbal and written communication skills., • Ability to work collaboratively in a team environment and demonstrate strong interpersonal skills., • Proven ability to be flexible and manage multiple tasks in a fast-paced, high-pressure setting., • Experience with CRO and vendor oversight is preferred., • Strong knowledge of clinical research and relevant regulatory requirements., • Proficiency in Microsoft Office Suite (Outlook, Word, Excel, etc.).

Job DescriptionDirector/Executive Director, Clinical Development Company: BioPhase Solutions Location: San Diego, CA Salary: $190k - $325k Yearly About BioPhase BioPhase is a leading provider of talent solutions in the biotechnology and pharmaceutical sectors, specializing in clinical development and research roles. We are currently seeking a strategic and experienced Director / Executive Director of Clinical Development to join our team in San Diego. Role Overview As the Director / Executive Director of Clinical Development, you will be a key member of the senior leadership team, responsible for driving the clinical development strategy for BioPhase’s portfolio. This role involves overseeing all aspects of clinical development, including strategy formulation, execution of clinical trials, and collaboration with key stakeholders such as principal investigators, consultants, and pharmaceutical partners. Key Responsibilities • Lead the development and execution of clinical strategies and plans for ongoing and pipeline programs., • Provide strategic direction across clinical operations, clinical science, medical monitoring, and regulatory affairs., • Oversee clinical trial design and execution to ensure compelling safety, efficacy, and pharmacokinetic data., • Manage relationships with principal investigators, key opinion leaders (KOLs), and external collaborators., • Coordinate and implement collaborative studies and regulatory activities with pharmaceutical and academic partners., • Ensure the recruitment, retention, and growth of a high-performing clinical development team., • Stay informed on industry trends, competitor activities, and relevant therapeutic developments., • Board Certified MD/PhD, or MD with significant experience in medical research and drug development., • At least 8 years of experience in the pharmaceutical or biotechnology industry, with a focus on oncology preferred., • Expertise in global clinical development, especially across Phase 1 to Phase 3 clinical studies., • Strong background in regulatory interactions, including familiarity with FDA/EMA GCP clinical requirements., • Demonstrated success in managing teams and building collaborative partnerships in the industry., • Excellent communication skills and the ability to present to diverse audiences, including investors and scientific communities.

Job Description JOB LOCATION/SCHEDULE: Monday – Friday / On-Site / San Diego, CA COMPANY OVERVIEW: At Alliance Clinical Network we’re people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day. Summary: The Clinical Research Compliance Specialist supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, writing monitoring reports, and developing risk monitoring plans and study-related documents. Essential Duties and Responsibilities: • Conduct SOP/GCP/Compliance Training with coordinators at site., • Ensure sites are adhering to ACN’ s policies and procedures., • Perform on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity., • Ensure valid findings from the audit/inspection report are managed effectively by the organization, and in accordance with our procedures. Escalate significant findings to CTNx Management., • Coach and Support CRCs and PIs on a continuous basis based upon audit findings., • Monitor the protocol and regulatory compliance of clinical research studies (with low —to high-risk research designs) in multiple treatment areas., • Review research data from source documentation for accuracy, completeness, and timeliness., • Collaborate with the offshore compliance team and the onsite study team to effectively address critical findings., • Strictly adhere to confidentiality and compliance standards., • Collect, review, maintain, and audit essential documents, • Assist with developing documents and implementing study-specific risk monitoring plans., • Support ongoing communication with study teams regarding trial qualification, initiation, monitoring, remote monitoring, and close-out activities., • Serves as the main point of contact in compliance audits and interim monitoring visits., • Read and comprehend new research protocols as well as amended protocols., • Meet assigned targets, goals, and completion deadlines., • Utilize analytical, problem-solving, and critical thinking., • Utilize precise attention to detail., • Perform other duties as assigned to meet the goals and objectives of the department and institution, • Comply with all company policies, procedures, and conduct. Qualification Requirements: To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions. Education and Experience: • An associate degree in healthcare or a related field is preferred., • At least two (2) years of clinical research experience as a Clinical Research Coordinator (CRC) or one (1) year of experience as a Clinical Research Associate (CRA) is required., • Proficient in Microsoft Word, Excel and Adobe Acrobat., • Working knowledge of medical and/or clinical trial terminology., • Working knowledge in relevant scientific fields., • Strong attention to detail., • Must be able to prioritize competing demands., • Must possess excellent verbal and written communication skills., • A proven ability to multi-task in a rapidly changing environment. Special Skills, Knowledge, and Abilities: • Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes., • Adapts quickly to changing priorities to perform as needed in his/her role., • Remains calm when faced with changes to (and in) his/her work., • Effectively relays understanding of diverse perspectives., • Can handle communication upwards and downwards as needed., • Presents information in a clear, well-thought-out way and tailored to the audience., • Shows support for the new direction even when the details have not been finalized., • Spots early indications of underperformance and takes corrective actions. Celebrates successes., • Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with to find solutions., • Supports the creation/implementation of data management plans by understanding site/study data sourcing techniques and overall compilation., • Independently assists data management tasks/processes in line with study-related data plans., • Identifies and resolves data queries and requirements based on knowledge of the origin, flow, and management of data through a clinical study., • Ensures compliance with SOPs related to data quality within assigned studies., • Contributes to study management and research procedures by consistently executing assigned tasks in compliance with GCP guidelines, with minimal supervision, • Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support)., • Shows awareness of basic safety, ethical, and HPP considerations, and regulatory requirements in terms of documentation and study conduct., • Assists in the development of relevant technical, study, and/or regulatory materials to ensure compliance with regulatory, safety, & ethical requirements. Certificates, Licenses, Registrations: Maintain GCP certification and other on-the-job certifications as required. Travel Required: 5-10% Physical Demands and Working Conditions: The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • While performing the duties of this job, the employee is regularly required to stand, walk, sit, kneel, use hands to finger, handle, or feel, and talk or hear., • The employee must occasionally lift and/or move up to 25 pounds., • This job requires Specific vision abilities, including close vision, depth perception, and the ability to adjust focus., • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job., • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • An essential function of the job is to be able to comply with all applicable federal, state and local safety and health regulations that would apply to this job., • The employee must move about the workspace to access work surface and shelves, cabinets, drawers, and equipment that are at, below or above the work surface., • Nothing in this job description limits management’s right to assign or reassign duties and responsibilities to this job at any time as business needs dictate. This job description reflects management’s assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned. The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor is it intended to be an all-inclusive list of the skills and abilities required to do the job. While every attempt has been made to outline the basic job responsibilities, adjustments in the process may change and expand the job duties. In addition, employees may be asked to perform duties outside of this description at the discretion of the Executive Management Team. BENEFITS: • 401 (k) Retirement Plan, • Medical, Dental, and Vision Insurance, • Paid Time Off (PTO), • Floating Holidays And more!

Job Description Position Overview Elite Clinical Network (ECN) is seeking a dedicated and research-oriented Physician – Dermatologist to join our expanding team of clinical professionals. The ideal candidate will play a critical role in the conduct of clinical trials by serving as a Principal Investigator (PI) or Sub-Investigator, while continuing to provide high-quality medical care to adult patients within a clinical research setting. This is a part time/per diem position with a unique opportunity to contribute to the advancement of medicine through clinical studies. Key Responsibilities • Serve as Principal Investigator or Sub-Investigator on multiple Phase I–IV clinical trials., • Perform comprehensive physical exams and clinical assessments for protocol screening and enrollment., • Evaluate patient eligibility based on inclusion/exclusion criteria of clinical protocols., • Provide medical oversight for clinical trial participants, including safety assessments, adverse event evaluations, and ongoing care., • Collaborate closely with Clinical Research Coordinators, Sponsors, and Monitors to ensure protocol compliance and data integrity., • Review and sign off on source documents, case report forms (CRFs), and regulatory documentation., • Maintain detailed and accurate clinical trial documentation in compliance with ICH-GCP, FDA, and sponsor requirements., • Participate in Site Initiation Visits (SIVs), Monitoring Visits, and Audits as needed., • Manage chronic and acute conditions among study participants in alignment with standard care and protocol guidelines., • Educate and counsel patients on study procedures, informed consent, and potential side effects., • Support recruitment efforts and promote patient retention in trials. Qualifications • MD or DO degree from an accredited medical school., • Valid, unrestricted medical license in the state of employment., • Board Certified or Board Eligible (BC/BE) in Dermatology., • BC/BE in Family Medicine or Geriatric Medicine will also be considered., • Current Good Clinical Practice (GCP) certification or willingness to obtain prior to start., • Minimum of 1 year of experience in clinical practice; prior clinical research experience preferred but not required. Preferred Skills • Familiarity with FDA, ICH-GCP, and clinical trial protocols., • Experience managing or participating in industry-sponsored clinical trials., • Strong attention to detail and ability to document accurately., • Excellent interpersonal and communication skills for patient interaction and sponsor collaboration., • Ability to work collaboratively with a cross-functional team in a fast-paced research environment., • Comfortable using electronic medical records (EMRs) and clinical trial management systems (CTMS)., • DEA license (preferred).

Job DescriptionMedical Director — Early Clinical Development (Oncology/Hematology)Location: San Diego, CA Employment Type: Full-time, direct hire Compensation: $350,000–$385,000 base (DOE) Travel: Up to ~25% Overview Lead early-phase clinical development for one or more programs. You’ll shape clinical strategy, design and execute Phase 1 studies, collaborate cross-functionally, and represent the program in regulatory and KOL settings—all with a focus on quality, speed, and patient impact. What you’ll do • Own clinical strategy and development plans for assigned molecules., • Design early-phase trials and ensure high-quality study conduct and GCP compliance., • Author/review study documents and interpret emerging clinical data to guide decisions., • Lead/participate in regulatory interactions as a clinical/medical representative., • Engage investigators and KOLs; support site start-up and ongoing execution., • Partner closely with preclinical/discovery, biometrics, and operations teams. What you bring, • MD or MD/PhD with oncology and/or hematology expertise., • 3+ years of biopharma experience in early development; Phase 1 (solid tumor or heme) preferred; small-molecule experience a plus., • Strong grasp of ICH/GCP, clinical trial design, and end-to-end study execution., • Clear communicator with sound judgment and problem-solving skills., • Ability to collaborate across disciplines and geographies; ~25% travel.

Job Description Position Overview: We are seeking a highly skilled and experienced Principal Investigator medical physician to join our team. As the Principal Investigator, you will be responsible for oversight of all clinical trial studies according to study protocols, company processes and GCP. This is a part-time position with flexible hours, ranging from 20 to 30 hours per week. The exact hours will vary based on the needs of the clinical trial study, offering both adaptability and the opportunity to work on a dynamic and engaging project. Responsibilities: • Ensure the medical safety of study participants., • Oversee site personnel in the execution and delivery of safe trial practices., • Review and report on screening failures, safety and participant retention rates., • Oversee clinical evaluation and assessments of clinical trial studies., • Interface with IRBs and study Sponsors on a regular basis., • Comply with all medical duties per study protocols, SOP, GCP and state regulations., • Collect and analyze data to identify patterns or trends of the clinical trials., • Prepare detailed reports documenting findings and recommendations for improvement., • Stay up-to-date with the latest developments in SOPs and documentation requirements. Qualifications: • Active and unrestricted Medical License - California., • 2 years experience as a Principal Investigator of Sub-Investigator, preferred. Although we are willing to train the right candidate., • Strong analytical skills with the ability to collect, analyze, and interpret complex data., • Excellent written and verbal communication skills for report writing and presenting findings, • Ability to effectively manage a team and prioritize tasks in a fast-paced environment., • Attention to detail and ability to maintain confidentiality when handling sensitive Information. If you are a highly motivated individual with a passion for clinical research, we encourage you to apply for this position. License/Certification: • DEA License (Required), • CA Medical Board Physician's License (Required)

Vice President Clinical Development - Respiratory Location: San Diego, CA (hybrid onsite preferred). Base Salary - $330-370k plus bonus and equity Scientific Search has recently partnered with an innovative pharmaceutical company who has tasked us in finding them an experienced and strategic Vice President of Clinical Development to lead clinical development programs across their respiratory pipeline. This role will report to the CMO and oversee Phase1-3 clinical trials. Responsibilities • Lead clinical strategy and trial execution from first-in-human through late-stage development, • Oversee clinical study design, CRO/vendor partnerships, data analysis, and safety reviews, • Collaborate cross-functionally with Regulatory, Pharmacovigilance, Biometrics, and Clinical Operations, • Represent Clinical Development to the executive team, Board, and external stakeholders., • Drive preparation of regulatory submission, study reports, and scientific publications Requirements • MD or MD/PhD with pulmonary specialty preferred., • 10+ years of clinical development experience, including Phase 2/3 studies in asthma/COPD., • Proven leadership in respiratory clinical trials and team management. How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume.